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D013927: Thrombosis

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (39)


Name (Synonyms) Correlation
drug812 Clopidogrel Wiki 0.29
drug24 1: Prone positioning Wiki 0.21
drug33 2: No instruction regarding positioning Wiki 0.21
Name (Synonyms) Correlation
drug3353 TEM-tPA Wiki 0.21
drug1204 Enoxaparin/Lovenox Intermediate Dose Wiki 0.21
drug3440 The Vie Scope laryngoscope Wiki 0.21
drug1084 Doppler Echo Wiki 0.21
drug2622 Prasugrel Hydrochloride 10 MG Oral Tablet Wiki 0.21
drug1197 Enoxaparin 1 mg/kg Wiki 0.21
drug861 Complete thrombophilic profile testing by multiplex PCR Wiki 0.21
drug2410 PT-Pal Wiki 0.21
drug1201 Enoxaparin Prefilled Syringe [Lovenox] Wiki 0.21
drug163 Acetylsalicylic acid Wiki 0.21
drug1467 Heparin SC Wiki 0.21
drug1199 Enoxaparin 40Mg/0.4Ml Inj Syringe 0.4Ml Wiki 0.21
drug3582 Unfractionated Heparin IV Wiki 0.21
drug3070 Self-guided exercises Wiki 0.21
drug1466 Heparin Infusion Wiki 0.21
drug1042 Diagnostic examination for venous thromboembolism Wiki 0.21
drug284 Apixaban 5MG Wiki 0.21
drug1346 Fondaparinux Wiki 0.21
drug283 Apixaban 2.5 MG Wiki 0.21
drug1108 Duplex ultrasound and Computed Tomography Angiography Wiki 0.21
drug3480 Tirofiban Injection Wiki 0.21
drug3790 assessment of the sequelae after hospitalization for Sars-COV-2 Wiki 0.21
drug1202 Enoxaparin Prophylactic Dose Wiki 0.21
drug1149 Echo-Doppler Wiki 0.21
drug20 18F-GP1 PET CT Wiki 0.21
drug3584 Unfractionated heparin SC Wiki 0.21
drug3445 The standard Macintosh laryngoscope Wiki 0.21
drug2244 Non-interventional Wiki 0.21
drug2468 Peripheral blood draw Wiki 0.15
drug1198 Enoxaparin 40 Mg/0.4 mL Injectable Solution Wiki 0.15
drug306 Aspirin Wiki 0.12
drug1196 Enoxaparin Wiki 0.11
drug2825 Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Wiki 0.10
drug2931 Ruxolitinib Wiki 0.07
drug2215 No intervention Wiki 0.05
drug2505 Placebo Wiki 0.02

Correlated MeSH Terms (20)


Name (Synonyms) Correlation
D020246 Venous Thrombosis NIH 0.69
D004617 Embolism NIH 0.47
D016769 Embolism and Thrombosis NIH 0.42
Name (Synonyms) Correlation
D054556 Venous Thromboembolism NIH 0.39
D013923 Thromboembolism NIH 0.39
D011655 Pulmonary Embolism NIH 0.38
D013924 Thrombophlebitis NIH 0.21
D020767 Intracranial Thrombosis NIH 0.21
D009203 Myocardial Ischemia NIH 0.15
D002546 Ischemic Attack, Transient NIH 0.15
D007238 Infarction NIH 0.13
D019851 Thrombophilia NIH 0.10
D054058 Acute Coronary Syndrome NIH 0.09
D009205 Myocarditis NIH 0.07
D016638 Critical Illness NIH 0.05
D011024 Pneumonia, Viral NIH 0.05
D011014 Pneumonia NIH 0.05
D045169 Severe Acute Respiratory Syndrome NIH 0.04
D018352 Coronavirus Infections NIH 0.03
D014777 Virus Diseases NIH 0.02

Correlated HPO Terms (8)


Name (Synonyms) Correlation
HP:0002625 Deep venous thrombosis HPO 0.66
HP:0001907 Thromboembolism HPO 0.46
HP:0002204 Pulmonary embolism HPO 0.35
Name (Synonyms) Correlation
HP:0004418 Thrombophlebitis HPO 0.21
HP:0002326 Transient ischemic attack HPO 0.15
HP:0001658 Myocardial infarction HPO 0.11
HP:0012819 Myocarditis HPO 0.07
HP:0002090 Pneumonia HPO 0.05

Clinical Trials

Navigate: Correlations   HPO

There are 23 clinical trials


1 In-vivo Thrombus Imaging With 18F-GP1, a Novel Platelet PET Radiotracer

To date, the investigators have successfully employed a radiotracer (18F-sodium fluoride) as a marker of necrotic inflammation in human atherosclerosis. The investigators aim to further the mechanistic understanding of atherothrombosis by studying the activation of glycoprotein IIb/IIIa receptors in cardiovascular thrombus using the novel platelet radiotracer (18F-GP1). Binding of 18F-GP1 to activated platelets in venous and arterial thrombi has already been demonstrated in pre-clinical studies and a phase 1 trial in man. If successful, this study would define the role of the glycoprotein IIb/IIIa receptor within in vivo thrombosis across a range of cardiovascular diseases.

NCT03943966
Conditions
  1. Thrombosis
  2. Atherothrombosis
  3. Myocardial Infarction
  4. STEMI
  5. NSTEMI - Non-ST Segment Elevation MI
  6. DVT
  7. Pulmonary Embolism
  8. Stroke
  9. Transient Ischemic Attack
  10. Prosthetic Valve Thrombosis
  11. PET
Interventions
  1. Diagnostic Test: 18F-GP1 PET CT
MeSH:Pulmonary Embolism Ischemic Attack, Transient Myocardial Infarction Thrombosis Embolism Infarction
HPO:Myocardial infarction Pulmonary embolism Transient ischemic attack

Primary Outcomes

Description: Expression of the glycoprotein IIb/IIIa receptor (assessed by SUV) within thrombus in the arterial and venous circulation.

Measure: Ratio of 18F-GP1 standardised uptake values (SUV's) in thrombus compared with the SUVs recorded in the blood pool.

Time: 6 months from end of recruitment

Secondary Outcomes

Description: Expression of the glycoprotein IIb/IIIa receptor (assessed by SUV) within thrombus in the arterial and venous circulation in all 5 disease states

Measure: Ratio of 18F-GP1 standardised uptake values (SUV's) in thrombus formed in each of the 5 disease states.

Time: 6 months from end of recruitment
2 Screening of Cardiovascular Complications in Patients With COVID-19

Patients with COVID-19 in the Intensive Care Unit (ICU) or hospitalized with severe form have a poor prognosis (almost 30% rate of death). They present often a high cardiovascular risk profile (almost 30% of hypertension and 19% of diabetes). Troponin has been described to be elevated in a high proportion of patients (one fifth of all patients and 50% of non-survivors) suggesting the possibility of cardiomyopathies. High levels of DDimers (81% of non survivors) and fibrin degradation products are also associated with increased risk of mortality suggesting also the possibility of venous thromboembolism. Therefore, screening for cardiomyopathies and venous thromboembolism could represent an important challenge for patients with COVID-19 management.

NCT04335162
Conditions
  1. COVID
  2. Acute Coronary Syndrome
  3. Myocardial Infarction
  4. Myocarditis
  5. Venous Thromboembolism
  6. Deep Vein Thrombosis
  7. Pulmonary Embolism
MeSH:Pulmonary Embolism Myocardial Infarction Thrombosis Acute Coronary Syndrome Thromboembolism Embolism Venous Thromboembolism Venous Thrombosis Myocarditis
HPO:Deep venous thrombosis Myocardial infarction Myocarditis Pulmonary embolism Thromboembolism Venous thrombosis

Primary Outcomes

Description: Incidence of cardiomyopathies and/or venous thromboembolism at day 28

Measure: Determine the incidence of cardiomyopathies and venous thromboembolism

Time: 28 days

Secondary Outcomes

Description: Incidence of mortality at day 28

Measure: Mortality

Time: 28 days

Description: Number of day of using mechanical ventilation for each patients

Measure: Duration of mechanical ventilation

Time: 28 days

Description: Incidence of shock at day 28

Measure: shock at day 28

Time: 28 days

Description: Number of day in intensive care unit

Measure: length of stay in the intensive care unit

Time: 28 days
3 COVID-19 and Deep Venous Thrombosis: a Cross-sectional Study

The aim of this study is to investigate the prevalence and possible risk factors of the occurrence of a DVT in 12 intubated and mechanically ventilated COVID-19 patients admitted to the ICU at a single time point (29/03/2020).

NCT04338932
Conditions
  1. COVID-19
  2. Deep Vein Thrombosis (DVT)/Thrombophlebitis
MeSH:Thrombosis Venous Thrombosis Thrombophlebitis
HPO:Deep venous thrombosis Thrombophlebitis Venous thrombosis

Primary Outcomes

Description: to investigate the prevalence of a DVT in patients at the ICU.

Measure: the prevalence of a DVT in patients at the ICU.

Time: 1 day at ICU

Secondary Outcomes

Description: evaluate pO2 and pCO2 (mmHg) in patients with and without a DVT

Measure: Oxygen partial pressure and Carbon dioxide partial pressure levels in the blood

Time: 1 day at ICU

Description: evaluate Potassium, Sodium, Calcium, Bicarbonate, Base excess, Lactate levels (mmol/l) in patients with and without a DVT

Measure: Potassium, Sodium, Calcium, Bicarbonate, Base excess, Lactate levels in the blood

Time: 1 day at ICU

Description: evaluate glucose, haemoglobin, ureum, creatinine, total bilirubin levels (mg/dl) in patients with and without a DVT

Measure: glucose, haemoglobin, ureum, creatinine, total bilirubin levels in the blood

Time: 1 day at ICU

Description: evaluate oxygen saturation, basophils, eosinophils, monocytes, neutrophils, haematocrit and prothrombine levels in the blood (%) in patients with and without a DVT

Measure: oxygen saturation, basophils, eosinophils, monocytes, neutrophils, haematocrit and prothrombine levels in the blood

Time: 1 day at ICU

Description: evaluate white blood cells (x 10*9/L), red blood cells (x 10*12/L) and platelets levels (x 109/L) in the blood in patients with and without a DVT

Measure: white blood cells, red blood cells and platelets in the blood

Time: 1 day at ICU

Description: evaluate PT (%)aPTT (sec)Fibrinogen (g/L)D-dimers (mg/L) PT (INR) (ratio) AST (U/L)ALT (U/L)Lactate dehydrogenase (U/L)Troponin T (ng/L)CRP (mg/L)Ferritin (mg/L) in the blood in patients with and without a DVT

Measure: PT (%)aPTT (sec)Fibrinogen (g/L)D-dimers (mg/L) PT (INR) (ratio) AST (U/L)ALT (U/L)Lactate dehydrogenase (U/L)Troponin T (ng/L)CRP (mg/L)Ferritin (mg/L)in the blood

Time: 1 day at ICU

Description: revalence of co morbidities such as Cardiovascular disease, n (%) Hypertension, n (%) Diabetes, n (%) Respiratory disease, n (%) Malignancy, n (%) Chronic renal disease, n (%) Chronic liver disease, n (%) Chronic bowel disease, n (%) Chronic nerve disease, n (%) Cerebrovascular disease, n (%) HIV/AIDS, n (%) Haematological disease, n (%) Obesity, n (%) Rheumatological disease, n (%) Dementia, n (%) in patients with and without a DVT admitted at the ICU in 1 day

Measure: prevalence of co-morbidities

Time: 1 day at ICU

Description: prevalence of vital signs such Temperature (°C) Breathing rate (#/min) Systolic blood pressure (mmHg) Mean arterial blood pressure (mmHg) Heart rate (#/min) Glasgow Coma Scale in patients with and without a DVT

Measure: prevalence of vital signs at icu admission

Time: at ICU admission

Description: prevalance of complications such as ARDS Acute kidney failure Acute heart failure Septic shock Secondary infection Seizure Stroke Hyperglaecemia Hypoglaecemia during ICU stay in patients with and without DVT

Measure: prevalence of complications during icu stay

Time: from ICU admission to cross sectional moment (29/3/2020)

Description: evaluation of treatment such as Antiviral treatment Antibiotic treatment Antifungal treatment Corticosteroid treatment CRRT IVIg treatment Plaquenil treatment during ICU stay in patients with and without DVT

Measure: evaluation of treatment

Time: from ICU admission to cross sectional moment (29/3/2020)

Description: evaluation of the oxygen therapy such as Invasive mechanical ventilation FiO2 (mmHg) PEEP Length of ventilationA ECMO Invasive mechanical ventilation + ECMO Vasopressor/inotropic support Neuromuscular blocking agents Prone ventilation in patients with and without DVT

Measure: evaluation of the oxygen therapy

Time: from ICU admission to cross sectional moment (29/3/2020)
4 Preventing COVID-19-associated Thrombosis, Coagulopathy and Mortality With Low- and High-dose Anticoagulation: a Multicentric Randomized, Open-label Clinical Trial

The ongoing COVID-19 pandemic affects millions of humans worldwide and has led to thousands of acute medical hospitalizations. There is evidence that hospitalized cases often suffer from an important infection-related coagulopathy and from elevated risks of thrombosis. Anticoagulants may have positive effects here, to reduce the burden of thrombotic disease and the hyperactivity of coagulation, and may also hold beneficial anti-inflammatory effects against sepsis and the development of ARDS. The investigators hypothesize that high-dose anticoagulants, compared with low-dose anticoagulants, lower the risk of venous and arterial thrombosis, disseminated intravascular coagulation (DIC) and mortality. This open-label controlled trial will randomize hospitalized adults with severe COVID-19 infection to therapeutic anticoagulation vs. thromboprophylaxis during the hospital stay.

NCT04345848
Conditions
  1. COVID
  2. Sars-CoV2
Interventions
  1. Drug: Enoxaparin
MeSH:Thrombosis

Primary Outcomes

Description: Risk of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality

Measure: Composite outcome of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality

Time: 30 days

Secondary Outcomes

Description: Risk of ischemic stroke, myocardial infarction and/or limb ischemia

Measure: Arterial thrombosis

Time: 30 days

Description: Risk of symptomatic venous thromboembolism or asymptomatic proximal leg deep vein thrombosis

Measure: Venous thromboembolism

Time: 30 days

Description: Risk of DIC

Measure: Disseminated intravascular coagulation

Time: 30 days

Description: Risk of all-cause mortality

Measure: All-cause mortality

Time: 30 days

Description: Risk of SIC

Measure: Sepsis-induced coagulopathy

Time: 30 days

Description: Risk of ARDS

Measure: Acute respiratory distress syndrome

Time: 30 days

Description: Number of days with these care processes

Measure: Durations of hospital stay, ICU stay, ventilation

Time: 30 days

Description: Highest score per participant

Measure: Sequential organ failure assessment score

Time: 30 days

Description: Risk of clinical deterioration

Measure: Clinical deterioration

Time: 30 days

Other Outcomes

Description: Risk of ISTH-defined major bleeding

Measure: Major bleeding

Time: 30 days

Description: Risk of ISTH-defined CRNMB

Measure: Clinically relevant non-major bleeding

Time: 30 days

Description: Risk of documented HIT

Measure: Heparin-induced thrombocytopenia

Time: 30 days
5 COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial

The purpose of this study is to evaluate the safety, dose-requirements, and exploratory efficacy of twice-daily subcutaneous enoxaparin as venous thromboembolism prophylaxis in children (birth to 18 years) hospitalized with signs and/or symptoms of SARS-CoV-2 infection (i.e., COVID-19).

NCT04354155
Conditions
  1. Infection Viral
  2. Thromboses, Venous
  3. COVID-19
Interventions
  1. Drug: Enoxaparin Prefilled Syringe [Lovenox]
MeSH:Virus Diseases Thrombosis Venous Thrombosis
HPO:Deep venous thrombosis Venous thrombosis

Primary Outcomes

Description: To investigate the safety of in-hospital thromboprophylaxis with twice-daily low-dose enoxaparin thromboprophylaxis as measured by cumulative incidence of ISTH-defined clinically-relevant bleeding events during hospitalization. Clinically relevant bleeding episodes may include any of the following: 1) fatal bleeding; 2) clinically overt bleeding associated with a decline in hemoglobin of ≥2g/dL in a 24h period; 3) retroperitoneal, pulmonary, or central nervous system bleeding; 4) bleeding requiring surgical intervention in an operating suite; 5) bleeding for which a blood product is administered (blood product administration not directly attributable to the patient's underlying condition); 6) bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating suite.

Measure: Safety of in-hospital thromboprophylaxis

Time: Day 30

Secondary Outcomes

Description: The median twice-daily enoxaparin dose, as measured in mg/kg, required to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL in children hospitalized with COVID-19, and to compare dose-requirements by age group (birth to <1 year old, 1-<6 years old, 6-<13 years old, and 13-<18 years old).

Measure: Median twice-daily enoxaparin dose

Time: 4 hours post initial dose

Other Outcomes

Description: To investigate, on a preliminary basis, the efficacy of in-hospital thromboprophylaxis with twice-daily enoxaparin in children hospitalized with COVID-19, as measured by the proportion of serial D-dimer levels obtained at standardized time points that are <2 times the upper limit of normal (<2x ULN) values for age.

Measure: Efficacy of in-hospital thromboprophylaxis as measured by the proportion of serial D-dimer levels

Time: Enrollment, Day 1, Day 2, and Day 3, 7, and 14 if still hospitalized

Description: To investigate, on a preliminary basis, the efficacy of in-hospital thromboprophylaxis with twice-daily enoxaparin in children hospitalized with COVID-19, as measured by confirmed HA-VTE.

Measure: Efficacy of in-hospital thromboprophylaxis as measured by confirmed HA-VTE

Time: Day 30

Description: To investigate, on a preliminary basis, the efficacy of in-hospital thromboprophylaxis with twice-daily enoxaparin in children hospitalized with COVID-19, as measured by median duration of in-hospital increased respiratory support (new requirement for high-flow nasal cannula, non-invasive ventilation, and/or mechanical ventilation, relative to any at-home baseline requirement).

Measure: Efficacy of in-hospital thromboprophylaxis as measured by median duration of increased respiratory support

Time: Day 30
6 Assessment of Endothelial and Haemostatic Changes During Severe SARS-CoV-2 Infection

The outbreak at covid-19 is caused by the SARS-CoV-2 virus. This virus can be responsible for severe respiratory failure but also for extra-respiratory organ dysfunctions associated with severe inflammatory stress. The endothelium is an important structure of the blood vessels and is implicated in the organ failure of many patients admitted in intensive care units. It could be affected by the virus and its alteration may explain the organ dysfunction of covid-19 ICU patients as well as the thrombotic processes frequently obstructed in this infection.

NCT04357847
Conditions
  1. Covid-19
  2. Endothelial Dysfunction
  3. Thrombosis
  4. Critically Ill
MeSH:Thrombosis Critical Illness

Primary Outcomes

Description: Plasma of covid-19 patients will be tested for endothelial injuries, notably with the measurement of InterCellular Adhesion Molecule 1 level by Enzym-Linked Immunosorbent Assay. The association of these levels with 28-days mortality will be evaluated as prognosis markers.

Measure: Association of InterCellular Adhesion Molecule-1 plasma level with 28 days mortality

Time: 24 hours

Secondary Outcomes

Description: Endothelin-1 will be assessed in blood as a maker of endothelial injuries, expressed in pg/mL. its association with 28 -days mortality will be evaluated.

Measure: Association of Endothelin-1 plasma level with 28 days mortality

Time: 24 hours

Description: Vascular Endothelial Growth Factor A plasma level will be measured in blood as a marker of endothelial injury expressed in pg/mL. its association with 28 -days mortality will be evaluated.

Measure: Association of Vascular Endothelial Growth Factor A plasma level with 28 days mortality

Time: 24 hours

Description: This soluble receptor is another marker of endothelial injury and will be measured in blood and expressed as pg/mL. Its association with 28-days mortality will be evaluated.

Measure: Association of soluble Vascular Endothelial Growth Factor Receptor type 1 with 28 days mortality

Time: 24 hours

Description: syndecan -1 is a marker of degradation of glycocalyx, raised during endothelial injury. It will be measured in blood and expressed as pg/mL. Its assocation with 28-days mortality will be evaluated.

Measure: Association of syndecan -1 plasma level with 28 days mortality

Time: 24 hours

Description: D-dimers si marker of enhanced thrombotic activity. It may be increased during covid-19 disease but its correlation with endothelial injury is not known. It will be measured in blood and expressed as microgrammes/L, and then correlated with ICAM-1 plasma levels

Measure: Association of D-dimers plasma levels with thrombotic events

Time: 24 hours

Description: This marker may be raised during endothelial injury and may explained thrombotic status of covid-19 patients. Its blood levels will be measured and expressed as international unit/dL, and correlated with ICAM-1 plasma levels

Measure: Association of von Willebrandt Factor with thrombotic events

Time: 24 hours

Description: Clot Stiffness and its fibrinogen and platelet contributions (expressed in kPa) will be measured as novative approach, using Quantra (Stago Inc) device, to explore hemostasis alterations of covid-19 patients.

Measure: Association of Viscoelastic testing with thrombotic events

Time: 24 hours
7 Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU

The main objective of the study is to determine the incidence of deep vein thromboses at Doppler echo in patients with SARS-Cov-2 pneumopathy upon their entry into ICU and after 7 days of hospitalization in ICU. This is a monocentric interventional study (RIPH 2).

NCT04363528
Conditions
  1. Deep Vein Thrombosis
Interventions
  1. Other: Doppler Echo
MeSH:Thrombosis Venous Thrombosis
HPO:Deep venous thrombosis Venous thrombosis

Primary Outcomes

Description: Deep vein thrombosis at Doppler echo

Measure: Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU

Time: Day 0

Description: Deep vein thrombosis at Doppler echo

Measure: Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU

Time: Day 7
8 Evaluation of TEM-tPA (Thromboelastometry With tPA) to Detect Covid-19 Patients at High Risk of Thrombosis

The coronavirus disease of 2019 (COVID-19) is a viral illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), now deemed a pandemic by the World Health Organization. Some COVID-19 patients may develop coagulopathy which is associated with poor prognosis and high risk of thrombosis. Some patients develop severe thrombotic complications, such as pulmonary embolism, despite anti-thrombotic prophylaxis by low molecular weight heparin. The aim of this project is to evaluate modified thromboelastometry for identifying patients at high risk of thrombosis. The hypothesize is that hypofibrinolysis with increased plasma PAI-1, TAFI (thrombin-activatable fibrinolysis inhibitor ) levels in association with high thrombin generation may explain high incidence of thrombosis in this population. A simple laboratory assay, widely available in hospitals, such as thromboelastometry, might be of great clinical interest to detect Covid-19 patients with high risk of thrombosis. In order to make ROTEM more sensitive to hypofibrinolysis, exogenous t-PA will be added in the assay. The preliminary results showed that patients with Covid-19 have significant hypercoagulability detectable with ROTEM and Covid-19 patients with thrombosis have both hypercoagulability and hypofibrinolysis.

NCT04366778
Conditions
  1. Thrombosis
  2. Covid-19
  3. SARS-CoV 2
Interventions
  1. Diagnostic Test: TEM-tPA
MeSH:Thrombosis

Primary Outcomes

Description: TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min)

Measure: Coagulability

Time: Day 0

Description: TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min)

Measure: Coagulability

Time: Day 3

Description: TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min)

Measure: Coagulability

Time: Day 6

Description: TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min)

Measure: Coagulability

Time: Day 9

Description: TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min)

Measure: Coagulability

Time: Day 12

Description: TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min)

Measure: Coagulability

Time: Day 15

Description: Occurence of VTE or arterial thrombosis during hospitalization : Pulmonary embolism diagnosed with CT scan Venous or arterial thrombosis diagnosed with ultrasound exam

Measure: Venous thrombotic event (VTE) or arterial thrombosis

Time: Day 15
9 Intermediate or Prophylactic-Dose Anticoagulation for Venous or Arterial Thromboembolism in Severe COVID-19: A Cluster Based Randomized Selection Trial (IMPROVE-COVID)

This study is being conducted to assess the effectiveness of intermediate versus prophylactic doses of anticoagulation (blood thinners) in patients critically ill with COVID-19 in the intensive care units (ICUs) throughout the hospital. Anticoagulation is part of the patient's usual standard of care but determining the dose of anticoagulation is based on physician preference. The investigators are conducting this study (a randomized trial with adaptive design employing cluster randomization) with the support of all of the ICUs to collect data in order to determine what should be the standard of care in terms of anticoagulation in these critically ill patients. The patients care will not be altered other than the choice of anticoagulation (both approved and used throughout the hospital as standard of care) based on the ICU bed they are assigned. Patient data will be collected until discharge.

NCT04367831
Conditions
  1. COVID-19
  2. Venous Thromboses
  3. Arterial Thrombosis
Interventions
  1. Drug: Enoxaparin Prophylactic Dose
  2. Drug: Heparin Infusion
  3. Drug: Heparin SC
  4. Drug: Enoxaparin/Lovenox Intermediate Dose
MeSH:Thrombosis Thromboembolism Venous Thrombosis
HPO:Deep venous thrombosis Thromboembolism Venous thrombosis

Primary Outcomes

Description: Composite of being alive and without clinically-relevant venous or arterial thrombotic events at discharge from ICU (without transfer to another ICU or palliative care unit/hospice) or at 30 days (if ICU duration lasted 30 days or longer).

Measure: Total Number of Patients with Clinically Relevant Venous or Arterial Thrombotic Events in ICU

Time: Discharge from ICU or 30 days

Secondary Outcomes

Description: Composite of being alive and without clinically-relevant venous or arterial thrombotic events at discharge from ICU (without transfer to another ICU or palliative care unit/hospice) or at 30 days (if ICU duration lasted 30 days or longer).

Measure: Total Number of Patients with In hospital Clinically Relevant Venous or Arterial Thrombotic Events

Time: Discharge from hospital or 30 days

Description: Length of stay measured in days.

Measure: ICU Length of Stay

Time: Discharge from ICU or 30 days

Description: The impact of intermediate-dose anti-coagulation compared with prophylactic anti-coagulation on rates of acute kidney injury and renal recovery in the ICU will be measured with the total number of patients who need of renal replacement therapy in the ICU.

Measure: Total Number of Patients with the Need for Renal Replacement Therapy in the ICU

Time: Discharge from hospital or 30 days

Description: Major bleeding will be assessed by BARC criteria, also explored by International Society on Thrombosis and Haemostasis (ISTH) and Thrombolysis in Myocardial Infarction (TIMI) criteria.

Measure: Total Number of Patients with Major bleeding in the ICU

Time: Discharge from hospital or 30 days

Description: Length of stay measured in days.

Measure: Hospital Length of Stay

Time: Discharge from hospital or 30 days
10 Platelet Inhibition With GP IIb/IIIa Inhibitor in Critically Ill Patients With Coronavirus Disease 2019 (COVID-19). A Compassionate Use Protocol

This is a compassionate use, proof of concept, phase IIb, prospective, interventional, pilot study in which the investigators will evaluate the effects of compassionate-use treatment with IV tirofiban 25 mcg/kg, associated with acetylsalicylic acid IV, clopidogrel PO and fondaparinux 2.5 mg s/c, in patients affected by severe respiratory failure in Covid-19 associated pneumonia who underwent treatment with continuous positive airway pressure (CPAP).

NCT04368377
Conditions
  1. Pneumonia, Viral
  2. Corona Virus Infection
  3. Respiratory Failure
  4. Embolism and Thrombosis
Interventions
  1. Drug: Tirofiban Injection
  2. Drug: Clopidogrel
  3. Drug: Acetylsalicylic acid
  4. Drug: Fondaparinux
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Respiratory Insufficiency Thrombosis Embolism Embolism and Thrombosis
HPO:Pneumonia Thromboembolism

Primary Outcomes

Description: Change in ratio between partial pressure of oxygen in arterial blood, measured by means of arterial blood gas analysis, and inspired oxygen fraction at baseline and after study treatment

Measure: P/F ratio

Time: At baseline and 24, 48 and 168 hours after treatment initiation

Description: Change in partial pressure of oxygen in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment

Measure: PaO2 difference

Time: At baseline and 24, 48 and 168 hours after treatment initiation

Description: Change in alveolar-arterial gradient of oxygen at baseline and after study treatment. Arterial alveolar gradient will be calculated using the following parameters derived from arterial blood gas analysis: partial pressure of oxygen in arterial blood and partial pressure of carbon dioxide in arterial blood.

Measure: A-a O2 difference

Time: At baseline and 24, 48 and 168 hours after treatment initiation

Secondary Outcomes

Description: Number of days on continuous positive end expiratory pressure (CPAP)

Measure: CPAP duration

Time: From the first day of study drugs administration (T0) until day 7 post study drugs administration

Description: Difference in intensity of the respiratory support (non invasive mechanical ventilation, CPAP, high flow nasal cannula (HFNC), Venturi Mask, nasal cannula, from higher to lower intensity, respectively) employed at baseline and at 72 and 168 hours after study treatment initiation

Measure: In-hospital change in intensity of the respiratory support

Time: At baseline and 72 and 168 hours after treatment initiation

Description: Difference in partial pressure of carbon dioxide in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment

Measure: PaCO2 difference

Time: At baseline and 24, 48 and 168 hours after treatment initiation

Description: Difference in concentration of bicarbonate in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment

Measure: HCO3- difference

Time: At baseline and 24, 48 and 168 hours after treatment initiation

Description: Difference in concentration of lactate in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment

Measure: Lactate difference

Time: At baseline and 24, 48 and 168 hours after treatment initiation

Description: Difference in hemoglobin concentration in blood samples, measured by means of blood chemistry test, at baseline and after study treatment.

Measure: Hb difference

Time: At baseline and 24, 48 and 168 hours after treatment initiation

Description: Difference in platelet concentration in blood samples, measured by means of blood chemistry test, at baseline and after study treatment.

Measure: Plt difference

Time: At baseline and 24, 48 and 168 hours after treatment initiation

Description: Any major or minor adverse effect occuring during and after the administration of the study drug (e.g. bleeding)

Measure: Adverse effects

Time: From the first day of study drugs administration until day 30 post study drugs administration
11 Effectiveness of Weight-adjusted Prophylactic Low Molecular Weight Heparin Doses Compared With Lower Fixed Prophylactic Doses to Prevent Venous Thromboembolism in COVID-2019. The Multicenter Randomized Controlled Open-label Trial COVI-DOSE

Worldwide observational studies indicate a significant prothrombogenic effect associated with SARS-CoV-2 infection with a high incidence of venous thromboembolism (VTE), notably life-threatening pulmonary embolism. According to recommendations for acute medical illnesses, all COVID-19 hospitalized patients should be given VTE prophylaxis such as a low molecular weight heparin (LMWH). A standard prophylactic dose (eg. Enoxaparin 4000IU once daily) could be insufficient in obese patients and VTE has been reported in patients treated with a standard prophylactic dose. In COVID-19 patients, guidelines from several international societies confirm the existence of an hypercoagulability and the importance of thromboprophylaxis but the "optimal dose is unknown" and comparative studies are needed. In view of these elements, carrying out a trial comparing various therapeutic strategies for the prevention of VTE in hospitalized patients with COVID-19 constitutes a health emergency. Thus, we hypothesize that an increased prophylactic dose of weight-adjusted LMWH would be greater than a lower prophylactic dose of LMWH to reduce the risk of life-threatening VTE in hospitalized patients. The benefit-risk balance of this increase dose will be carefully evaluated because of bleeding complications favored by possible renal / hepatic dysfunctions, drug interactions or invasive procedures in COVID-19 patients. This multicenter randomized (1:1) open-label controlled trial will randomize hospitalized adults with COVID-19 infection to weight-adjusted prophylactic dose vs. lower prophylactic dose of LMWH.

NCT04373707
Conditions
  1. COVID
  2. Thrombosis
  3. Pulmonary Embolism
  4. Deep Vein Thrombosis
Interventions
  1. Drug: Enoxaparin
  2. Drug: Enoxaparin
MeSH:Pulmonary Embolism Thrombosis Thromboembolism Embolism Venous Thromboembolism Venous Thrombosis
HPO:Deep venous thrombosis Pulmonary embolism Thromboembolism Venous thrombosis

Primary Outcomes

Description: Risk of deep vein thrombosis or pulmonary embolism or venous thromboembolism-related death

Measure: Venous thromboembolism

Time: 28 days

Secondary Outcomes

Description: Risk of major bleeding defined by the ISTH

Measure: Major bleeding

Time: 28 days

Description: Risk of Major Bleeding and Clinically Relevant Non-Major Bleeding Defined by the ISTH

Measure: Major Bleeding and Clinically Relevant Non-Major Bleeding

Time: 28 days

Description: Risk of Venous Thromboembolism and Major Bleeding

Measure: Net Clinical Benefit

Time: 28 days and 2 months

Description: Risk of venous thrombosis at other sites: e.g. superficial vein, catheters, hemodialysis access, ECMO, splanchnic, encephalic, upper limb

Measure: Venous Thromboembolism at other sites

Time: 28 days

Description: Risk of arterial thrombosis at any sites

Measure: Arterial Thrombosis

Time: 28 days

Description: Risk of all-cause mortality

Measure: All-Cause Mortality

Time: 28 days and 2 months

Description: Identification of associations between the risk of venous thromboembolism and clinical (eg. past medical history of thrombosis, cardiovascular risk factors, treatments, severity of COVID-19) and laboratory variables (e.g. D-dimers, fibrinogen, CRP) collected in the eCRF

Measure: Factors associated with the risk of venous thromboembolism

Time: 28 days
12 Risk of Venous Thromboembolism in Critically Ill Patients With Severe COVID-19

Severe COVID-19 patients at a high risk of venous thromboembolism. We studied patients in 2 intensive care units of university hospitals in Barcelona and Badalona, Spain. We performed a cut-off screening of deep venous thrombosis (DVT) with bilateral duplex ultrasound to 230 patients.

NCT04374617
Conditions
  1. COVID-19
  2. Critical Illness
  3. Venous Thromboembolism
  4. Venous Thromboses
  5. Venous Thromboses, Deep
  6. Venous Thrombosis Pulmonary
  7. Pulmonary Embolism
  8. Pulmonary Embolism and Thrombosis
  9. Sars-CoV2
  10. SARS-CoV Infection
Interventions
  1. Diagnostic Test: Duplex ultrasound and Computed Tomography Angiography
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pulmonary Embolism Thrombosis Thromboembolism Embolism Venous Thromboembolism Venous Thrombosis Embolism and Thrombosis Critical Illness
HPO:Deep venous thrombosis Pulmonary embolism Thromboembolism Venous thrombosis

Primary Outcomes

Description: Patients with symptomatic pulmonary embolism confirmed on the CT-angiography and those with a swollen limb and confirmed deep venous thrombosis on compression ultrasound were considered to have "symptomatic venous thromboembolisms". The remaining patients with positive limb ultrasound or CT-angiography were considered to have "asymptomatic venous thrombembolism"

Measure: Venous thromboembolisms

Time: 7 days

Secondary Outcomes

Description: Deaths from all causes during the follow-up

Measure: Deaths

Time: 7 days
13 Study of the Prevalence of Deep Vein Thrombosis in Patients Hospitalized in Intensive Care for Acute Respiratory Failure Linked to Pneumonia Documented With SARS-COV2

Coronavirus 2 (SARS-CoV2) has been identified as the pathogen responsible for severe acute respiratory syndrome associated with severe inflammatory syndrome and pneumonia (COVID-19). Haemostasis abnormalities have been shown to be associated with a poor prognosis in these patients with this pneumonia. In a Chinese series of 183 patients, the hemostasis balance including thrombin time, fibrinogenemia, fibrin degradation products and antithrombin III were within normal limits. Only the D-Dimer assay was positive in the whole cohort with an average rate of 0.66 µg / mL (normal <50 µg / mL). These hemostasis parameters were abnormal mainly in patients who died during their management; the levels of D-dimers and fibrin degradation products were significantly higher while the antithrombin III was reduced. The findings on the particular elevation of D-dimers in deceased patients as well as the significant increase in thrombin time were also reported in another series. Higher numbers of pulmonary embolisms have been reported in patients with severe form of SARS-COV2 (data in press). This research is based on the hypothesis that the existence of deep vein thrombosis (DVT) could make it possible to screen patients at risk of pulmonary embolism and to set up a curative anticoagulation. The main objective is to describe the prevalence of deep vein thrombosis in patients hospitalized in intensive care for acute respiratory failure linked to documented SARS-COV2 pneumonia, within 24 hours of their admission.

NCT04388657
Conditions
  1. COVID
  2. Embolism and Thrombosis
  3. Pneumonia, Viral
Interventions
  1. Diagnostic Test: Echo-Doppler
MeSH:Pneumonia, Viral Pneumonia Thrombosis Embolism Embolism and Thrombosis
HPO:Pneumonia Thromboembolism

Primary Outcomes

Description: The primary outcome measure will be the percentage of patients with one or more DVTs from a lower extremity ultrasound scan.

Measure: percentage of patients with one or more DVTs.

Time: 28 days
14 Enoxaparin for Primary Thromboprophylaxis in Ambulatory Patients With Coronavirus: The Multicenter Randomized Controlled Ovid Trial

The OVID study will show whether prophylactic-dose enoxaparin improves survival and reduces unplanned hospitalizations in ambulatory patients aged 50 or older diagnosed with COVID-19, a novel viral disease characterized by severe systemic, pulmonary, and vessel inflammation and coagulation activation.

NCT04400799
Conditions
  1. COVID-19
  2. Pulmonary Embolism, Deep Vein Thrombosis
Interventions
  1. Drug: Enoxaparin 40Mg/0.4Ml Inj Syringe 0.4Ml
MeSH:Pulmonary Embolism Thrombosis Embolism Venous Thrombosis
HPO:Deep venous thrombosis Pulmonary embolism Venous thrombosis

Primary Outcomes

Measure: hospitalizations

Time: 30 days

Measure: all-cause death

Time: 30 days

Secondary Outcomes

Description: including deep vein thrombosis (including catheter-associated), pulmonary embolism, myocardial infarction/myocarditis, arterial ischemia including mesenteric and extremities, acute splanchnic vein thrombosis, or ischemic stroke

Measure: Number of cardiovascular events

Time: within 14 days, 30 days, and 90 days of randomization

Measure: any hospitalizations

Time: within 14 days, 30 days, and 90 days of randomization

Measure: all-cause death

Time: within 14 days, 30 days, and 90 days of randomization

Description: measured by number of cardiovascular events, and major bleeding

Measure: Net clinical benefit

Time: within 14 days, 30 days, and 90 days of enrolment.

Description: ISTH criteria, in-hospital diagnosis

Measure: Disseminated intravascular coagulation

Time: within 14 days, 30 days, and 90 days of enrolment
15 Prevalence and Severity of Venous Thromboembolism in a General Population During the COVID-19 Pandemic

The purpose of this study is to investigate the prevalence of venous thromboembolism in a regional health care system (Region Östergötland, Sweden) before and during the SARS-COV-2 pandemic. In a retrospective observational study, we will review patient data, diagnostic data and treatment data over a three-month period since the onset of the SARS-COV-2 pandemic. This data will be compared with data from the corresponding time frame during the years 2015 to 2019.

NCT04400877
Conditions
  1. COVID-19
  2. Venous Thromboembolism
  3. Pulmonary Embolism
  4. Deep Vein Thrombosis
  5. SARS-CoV 2
Interventions
  1. Diagnostic Test: Diagnostic examination for venous thromboembolism
MeSH:Pulmonary Embolism Thrombosis Thromboembolism Embolism Venous Thromboembolism Venous Thrombosis
HPO:Deep venous thrombosis Pulmonary embolism Thromboembolism Venous thrombosis

Primary Outcomes

Measure: Is there an increased prevalence of venous thromboembolism in a regional healthcare system in Sweden during the SARS-CoV-2 pandemic?

Time: March to May in 2020

Measure: Is a SARS-CoV-2-infection an isolated risk factor for thromboembolism?

Time: March to May in 2020

Secondary Outcomes

Measure: Are there geographic differences in the prevalence of venous thromboembolism within the healthcare system?

Time: March to May in 2020

Measure: Is venous thromboembolism associated with increased mortality adjusted for relevant comorbidities?

Time: March to May in 2020

Measure: How long is the time between symptom onset of the SARS-CoV-2-infection and any subsequent venous thromboembolism?

Time: March to May in 2020

Measure: Is treatment with prophylactic antithrombotic or anticoagulant treatment associated with increased survival?

Time: March to May in 2020
16 Coagulopathy Associated With Coronavirus disease19 (CA-COVID19) A Multi-Centre Observational Study in UK

A novel Coronavirus (COVID-19) infection leading to pneumonia and severe acute respiratory failure [acute respiratory distress syndrome (ARDS)] and death is a global threat. On 11/03/2020, WHO declared the Covid-19 outbreak a global pandemic. As of 18th of March, there are 202,309 confirmed cases with 8,013 deaths. Patients with severe illness may develop dyspnoea and hypoxemia within 1week after onset, which may quickly progress to ARDS or end-organ failure 1. Based on Chinese data abnormal coagulation parameters (Prolonged Prothrombin time [PT] and raised D dimer) are reported to predict a poor prognosis and may therefore be important therapeutic targets. The number of patients with infected with COVID- 19 in UK is rapidly rising as with many other European countries. Eventually >50% of people will have become infected and COVID-19 will remain a public health threat in the long term. It is therefore very important to understand every aspect of this disease, including the associated coagulopathy leading bleeding, blood clots (thrombosis) and death. Emerging data from Europe and some centres in UK, indicates that venous thromboembolism (VTE), mainly pulmonary embolism (PE), is major problem in COVID patients. In this retrospective-prospective: multicentre study, investigators will document the patient characteristics, presenting haematological parameters and associated comorbidities and their association with bleeding, thrombosis and mortality in patients admitted for hospital treatment. Determining the predictive value of patient characteristics and presenting laboratory measurements for clinical outcomes in these patients will allow us to optimise management of these patients in the future. Furthermore, by comparing these data with data from patients without Covid-19, investigators will be able to modify existing protocols and tailor them to the management of COVID -19.

NCT04405232
Conditions
  1. COVID
  2. Thrombosis
  3. Bleeding
  4. Anticoagulation
Interventions
  1. Other: Non-interventional
MeSH:Thrombosis

Primary Outcomes

Measure: Prevalence and characteristics of coagulation abnormalities and their predictive value for respiratory failure requiring ventilation, multiorgan failure and death in patients presenting with COVID 19 infection

Time: 12 months

Secondary Outcomes

Measure: Incidence of respiratory failure requiring CPAP or mechanical ventilation

Time: 12 months

Measure: Incidence of thrombosis (clinical or radiological diagnosis) including thrombosis within 90 days after hospital admission (hospital associated thrombosis) 4. Incidence of minor bleeding 5. Heparin induced thrombocytopenia 6. Acute coronary syndrome

Time: 12 months

Measure: Incidence of major bleeding 8. Multiorgan failure 9. Development of DIC 10. Duration of hospital stay (days) 11. Hospital mortality

Time: 12 months

Measure: Incidence of clinically relevant non-major bleeding

Time: 12 months

Measure: Incidence of Heparin induced thrombocytopenia

Time: 12 months

Measure: Incidence of Acute coronary syndrome

Time: 12 months

Measure: Incidence of renal failure requiring renal replacement therapy

Time: 12 months

Measure: Incidence of Multiorgan failure

Time: 12 months

Measure: Incidence of Development of DIC

Time: 12 months

Measure: Duration of hospital stay (days)

Time: 12 months

Measure: Hospital mortality

Time: 12 months
17 A Multicenter, Randomized-Controlled Trial to Evaluate the Efficacy and Safety of Antithrombotic Therapy for Prevention of Arterial and Venous Thrombotic Complications in Critically-Ill COVID-19 Patients

This is a multicenter, open-label, 2x2 factorial, randomized-controlled trial in critically-ill patients with novel coronavirus disease 2019 (COVID-19) evaluating the efficacy and safety of full-dose vs. standard prophylactic dose anticoagulation and of antiplatelet vs. no antiplatelet therapy for prevention of venous and arterial thrombotic events.

NCT04409834
Conditions
  1. COVID-19
  2. Venous Thromboembolism
  3. Arterial Thrombosis
Interventions
  1. Drug: Unfractionated Heparin IV
  2. Drug: Enoxaparin 1 mg/kg
  3. Drug: Clopidogrel
  4. Drug: Unfractionated heparin SC
  5. Drug: Enoxaparin 40 Mg/0.4 mL Injectable Solution
MeSH:Thrombosis Thromboembolism Venous Thromboembolism
HPO:Thromboembolism

Primary Outcomes

Description: Hierarchical composite: Death due to venous or arterial thrombosis, pulmonary embolism, clinically evident DVT, type 1 MI, ischemic stroke, systemic embolism or acute limb ischemia, or clinically silent DVT

Measure: Primary endpoint: Venous or arterial thrombotic events

Time: 28 days or until hospital discharge, whichever earlier

Secondary Outcomes

Description: Hierarchical composite: Death due to venous or arterial thrombosis, pulmonary embolism, clinically evident DVT, type 1 MI, ischemic stroke, systemic embolism or acute limb ischemia

Measure: Key secondary endpoint: Clinically evident venous or arterial thrombotic events

Time: 28 days or until hospital discharge, whichever earlier
18 Thrombosis Risk Assessment May Predict Clinical Presentation and Length of Hospital Stay in Covid-19 Pneumonia

Covid-19 mainly affects the respiratory system. Multiple organ dysfunction and a particularly progressive respiratory insufficiency along with a widespread coagulopathy presumed to be due to infection-associated inflammation and the resulting cytokine storm, are strongly associated with high mortality rates. In this study, the association between thrombosis risk and clinical presentation of Covid-19 is investigated.

NCT04423315
Conditions
  1. Corona Virus Infection
  2. Thromboembolic Disease
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Thrombosis Thromboembolism
HPO:Pneumonia Thromboembolism

Primary Outcomes

Description: from admission to discharge expressed in days

Measure: length of hospital stay

Time: 2 months
19 Prasugrel in the Prevention of Severe SARS-CoV2 Pneumonia in Hospitalised Patients

Inflammatory diseases favour the onset of venous thromboembolic events in hospitalized patients. Thromboprophylaxis with a fixed dose of heparin/low molecular weight heparin (LMWH) is recommended if concomitant inflammatory disease. In severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) pneumonia an inflammation-dependent thrombotic process occurs and platelet activation may promote thrombosis and amplify inflammation, as indicated by previous experimental evidence , and the similarities with atherothrombosis and thrombotic microangiopathies. Antiplatelet agents represent the cornerstone in the prevention and treatment of atherosclerotic arterial thromboembolism, with limited efficacy in the context of venous thromboembolism. The use of purinergic receptor P2Y12 inhibitors in pneumococcal pneumonia may improve inflammation and respiratory function in humans. There are no validated protocols for thrombosis prevention in Covid-19. There is scientific rationale to consider a P2Y12 inhibitor for the prevention of thrombosis in the pulmonary circulation and attenuation of inflammation. This is supported by numerous demonstrations of the anti-inflammatory activity of P2Y12 inhibitors and the evidence of improvement in respiratory function both in human and experimental pathology. Prasugrel could be considered as an ideal candidate drug for Covid-19 patients because of higher efficacy and limited Interactions with drugs used in the treatment of Sars-CoV2. The hypothesis underlying the present study project is that in Covid-19 platelet activation occurs through an inflammation-dependent mechanism and that early antithrombotic prophylaxis in non-critical patients could reduce the incidence of pulmonary thrombosis and respiratory and multi-organ failure improving clinical outcome in patients with SARS-CoV2 pneumonia. The prevention of thrombogenic platelet activity with a P2Y12 inhibitor could be superior to fixed dose enoxaparin alone. The proposed treatment is feasible in all coronavirus disease 2019 (COVID-19) patients, regardless of the treatment regimen (antivirals, anti-inflammatory drugs, antibiotics), except for specific contraindications.

NCT04445623
Conditions
  1. COVID19
  2. Thrombosis
Interventions
  1. Drug: Prasugrel Hydrochloride 10 MG Oral Tablet
  2. Drug: Placebo
MeSH:Pneumonia Thrombosis
HPO:Pneumonia

Primary Outcomes

Description: PaO2/FiO2 ratio (arterial oxygen tension divided by the fraction of inspired oxygen) detected after 7 days of treatment

Measure: P/F ratio at day 7

Time: day 7

Secondary Outcomes

Description: PaO2/FiO2 ratio (arterial oxygen tension divided by the fraction of inspired oxygen) detected daily for 15 days

Measure: Daily P/F ratio

Time: 15 days

Description: daily need for oxygen supply for 15 days

Measure: Daily need for oxygen supply

Time: 15 days

Description: Number of patients requiring transfer to the intensive care unit (ICU) by treatment arm

Measure: Need for ICU

Time: day 15 and day 30

Description: death by day 15 and day 30 by treatment arm

Measure: Death

Time: 15 day and day 30

Description: Multi-organ failure (MOF) by day 15 and day 30 assessed using sequential organ failure assessment score (SOFA) score (Units 0-4 better outcome, over 30 worse outcome) by treatment arm

Measure: MOF

Time: day 15 and day 30

Description: Number of patients discharged after improvement by day 15 and day 30 by treatment arm

Measure: Discharge

Time: day 15 and day 30

Description: Clinical progression of the disease evaluated by SOFA score (Units 0-6 better outcome, 15-24 worse outcome) by day 15 and day 30

Measure: Clinical progression of the disease SOFA score

Time: day 15 and day 30

Description: Clinical progression of the disease evaluated by Acute Physiology And Chronic Health Evaluation (APACHE II) score (Units 1-5 better outcome, over 30 worse outcome) by day 15 and day 30

Measure: Clinical progression of the disease APACHE II

Time: day 15 and day 30

Description: Number of patients with venous thrombosis/ pulmonary embolism/thrombosis by day 15 and day 30

Measure: Venous thrombosis/ pulmonary embolism/thrombosis

Time: day 15 and day 30

Description: Number of patients requiring computerized tomography (CT) imaging due to worsening of respiratory function by treatment arm

Measure: Need for CT imaging

Time: day 15

Description: Body temperature measured twice daily for 15 days, C°

Measure: Daily Temperature

Time: 15 days

Description: Blood pressure measured twice daily for 15 days, mmHg

Measure: Daily blood pressure

Time: 15 days

Description: Total blood count measured in venous blood for 15 days, Hemoglobin, g/L (cell/mcL

Measure: Daily total blood count Hemoglobin

Time: 15 days

Description: Total blood count measured in venous blood for 15 days, Red Blood cells (cell/mcL)

Measure: Daily total blood count Red Blood Cells

Time: 15 days

Description: Total blood count measured in venous blood for 15 days, Leukocytes (cell/mcL)

Measure: Daily total blood count Leukocytes

Time: 15 days

Description: Total blood count measured in venous blood for 15 days, platelets (cell/mcL)

Measure: Daily total blood count Platelets

Time: 15 days

Description: ALT U/L in venous blood

Measure: Daily indices of organ damage Liver

Time: 15 days

Description: C-reactive protein microg/L in venous blood

Measure: Indices of inflammation C-reactive protein

Time: day 1, 2, 7, 15

Description: PT ratio in venous blood by treatment arm

Measure: Indices of haemostasis PT

Time: day 1, 2, 7,15

Description: progression of lung infiltrates as detected by chest-X-ray by treatment arm

Measure: Daily progression at imaging (chest-X-ray)

Time: 15 days

Description: Major and/or clinically relevant bleeding according to International Society of Thrombosis and Haemostasis (ISTH) bleeding scale (Unit 0 better outcome, 4 worse outcome, 11 items) during treatment.

Measure: Major bleeding

Time: day 1, 2, 7, 15, 30

Description: Total bleeding according to International Society of Thrombosis and Haemostasis (ISTH bleeding) scale (Unit 0 better outcome, 4 worse outcome, 11 items) during treatment.

Measure: Total bleeding

Time: day 1, 2, 7, 15, 30

Description: Number of unexpected changes in clinical or laboratory findings not included in the predefined list of outcomes during treatment. .

Measure: Unexpected clinical or laboratory findings

Time: day 1, 2, 7, 15

Description: D-dimer microg/L in venous blood

Measure: Indices of inflammation D-dimer

Time: day 1, 2, 7, 15

Description: Fibrinogen g/L in venous blood

Measure: Indices of inflammation Fibrinogen

Time: day 1, 2, 7, 15

Description: Interleukin (IL)-6 pg/mL in venous blood by treatment arm

Measure: Indices of inflammation IL-6

Time: day 1, 2, 7, 15

Description: Interleukin (IL)-1 pg/mL in venous blood by treatment arm

Measure: Indices of inflammation IL-1

Time: day 1, 2, 7, 15

Description: serum creatinine micromol/L by treatment arm

Measure: Daily indices of organ damage kidney

Time: 15 days

Description: troponin t ng/L by treatment arm

Measure: Daily indices of organ damage heart

Time: 15 days

Description: aPTT ratio by treatment arm

Measure: Haemostasis aPTT

Time: day 1, 2, 7,15

Description: Vasodilator stimulated phosphoprotein (VASP) phosphorylation (PRI) % by treatment arm

Measure: Haemostasis VASP PRI

Time: day 1, 2, 7,15

Description: Platelet-leukocytes aggregates % in peripheral by treatment arm

Measure: Haemostasis platelet-leukocytes aggregates

Time: day 1, 2, 7,15
20 High Prevalence of Deep Venous Thrombosis in Non-severe COVID-19 Patients Hospitalized for a Neurovascular Pathology

Severe SARS-CoV-2 infection, responsible of COVID-19, is accompanied by many venous thromboembolic events. Antithrombotic treatment is the cornerstone of management of many neurovascular diseases (NVDs) and the benefit-risk ratio is crucial to avoid hemorrhagic complications. Therefore, in non-severe COVID-19 patients affected by NVDs, the diagnostic of deep venous thrombosis (DVT) is challenging. Using bedside Doppler ultrasonography (DUS) of lower limbs, this study investigated the rates of DVT in these patients in stroke unit.

NCT04452422
Conditions
  1. Deep Venous Thrombosis
MeSH:Thrombosis Venous Thrombosis
HPO:Deep venous thrombosis Venous thrombosis

Primary Outcomes

Measure: Number of cumulated deep venous thrombosis among the hospitalization

Time: Day 7 after admisssion
21 COVID-19 Outpatient Thrombosis Prevention Trial: A Multi-center Adaptive Randomized Placebo-controlled Platform Trial Evaluating the Efficacy and Safety of Anti-thrombotic Strategies in COVID-19 Adults Not Requiring Hospitalization at Time of Diagnosis

A multi-center adaptive randomized placebo-controlled platform trial evaluating the efficacy and safety of anti-thrombotic strategies in COVID-19 adults not requiring hospitalization at time of diagnosis

NCT04498273
Conditions
  1. COVID-19
Interventions
  1. Drug: Apixaban 2.5 MG
  2. Drug: Apixaban 5MG
  3. Drug: Aspirin
  4. Drug: Placebo
MeSH:Thrombosis

Primary Outcomes

Description: The primary outcome will be a composite endpoint of need for hospitalization for cardiovascular/pulmonary events, symptomatic deep venous thrombosis, pulmonary embolism, arterial thromboembolism, myocardial infarction, ischemic stroke, and all-cause mortality for up to 45 days after initiation of assigned treatment.

Measure: Primary

Time: 45 days
22 Investigating the Involvement of ACE and Angiotensinogen Genes' Polymorphism Along With Other Thrombophilic Genotypes in Severe Forms of COVID-19 With/Without Thrombotic Events

An estimated 22% of the global population is at an increased risk of a severe form of COVID-19, while one in four coronavirus patients admitted to intensive care unit will develop a pulmonary embolism. A major public health question remains to be investigated: why COVID-19 is mild for some, critically severe for others and why only a percentage of COVID-19 patients develop thrombosis, despite the disease's proven hypercoagulable state? Patients' intrinsic characteristics might be responsible for the deep variety of disease forms. Our study aims to assess the validity of the hypothesis according to which underlining genetic variations might be responsible for different degrees of severity and thrombotic events risks in the novel coronavirus disease. Moreover, we suspect that prothrombotic genotypes occuring in the genes that encode angiotensin-converting enzyme (ACE-DEL/INS) and angiotensinogen (AGT M235T) are involved in the unpredictable evolution of COVID-19, both in terms of severity and thrombotic events, due to the strong interactions of SARS-CoV-2 with the renin-angiotensin-aldosterone system (RAAS). Therefore, we also aim to assess the validity of the theory according to which there is a pre-existing atypical modulation of RAAS in COVID-19 patients that develop severe forms and/or thrombosis. Our hypothesis is based on various observations. Firstly, there is a substantial similarity with a reasonably related condition such as sepsis, for which there is a validated theory stating that thrombophilic mutations affect patients' clinical response. Secondly, racial and ethnic genetic differences are responsible for significant dissimilar thrombotic risks among various nations. Thirdly, an increase in stroke incidence has been reported in young patients with COVID-19, without essential thrombosis risk factors, favoring the idea that a genetic predisposition could contribute to increase the thrombotic and thromboembolic risk. Fourthly, the plasminogen activator inhibitor (PAI)-1 4G/5G inherited mutation was found to be responsible for a thrombotic state causing post-SARS osteonecrosis.

NCT04519398
Conditions
  1. Covid19
  2. Corona Virus Infection
  3. Thrombosis
  4. ARDS
  5. Thrombophilia
  6. Thromboses, Intracranial
  7. Thromboses, Deep Vein
  8. RAAS
Interventions
  1. Genetic: Complete thrombophilic profile testing by multiplex PCR
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Intracranial Thrombosis Thrombosis Venous Thrombosis Thrombophilia
HPO:Deep venous thrombosis Hypercoagulability Venous thrombosis

Primary Outcomes

Description: The difference of prothrombotic genotypes frequency between the three groups

Measure: Number of patients with thrombophilic profile alterations

Time: One year

Secondary Outcomes

Description: The differences of RAAS components levels between the three groups

Measure: Number of patients with RAAS components alterations

Time: One year
23 COVID-19 Registry to Assess Frequency, Risk Factors, Management, and Outcomes of Arterial and Venous Thromboembolic Complications (CORONA-VTE NETWORK)

Novel coronavirus 2019 (COVID-19) has emerged as a major international public health concern. While much of the morbidity and mortality associated with COVID-19 has been attributed to acute respiratory distress syndrome (ARDS) or end-organ failure, emerging data suggest that disorders of coagulation, in particular hypercoagulability and venous thromboembolism (VTE), may represent an additional major, and possibly preventable, complication (Wu C, et al. JAMA Intern Med. 2020 Mar 13. [Epub ahead of print] and Tang N, et al. Thromb. Haemost. 2020 Feb 19. [EPub Ahead of Print]). Abnormal coagulation testing results, especially markedly elevated D-dimer and FDP, have been associated with a poor prognosis in COVID-19 infection. We propose the following Electronic Health Record (EHR)-guided 10000-patient, retrospective observational cohort study to assess VTE incidence, risk factors, prevention and management patterns, and thrombotic outcomes in patients with COVID-19 infection. In order to gain the valuable perspective of other regional and national centers providing care for large populations of COVID-19, we have started a collaborative network with 5 additional sites which will provide us with de-identified data from 1000 patients each. These 5000 patients in addition to the 5000-patient cohort we are enrolling within the Mass General Brigham Network will comprise this study population.

NCT04535128
Conditions
  1. Covid19
  2. Thrombosis Embolism
  3. DVT
  4. Pulmonary Embolism
  5. Myocardial Infarction
  6. Stroke
Interventions
  1. Other: No intervention
MeSH:Pulmonary Embolism Myocardial Infarction Thrombosis Embolism Embolism and Thrombosis Infarction
HPO:Myocardial infarction Pulmonary embolism Thromboembolism

Primary Outcomes

Description: Frequency (%) of arterial or venous thromboembolism

Measure: Frequency of arterial or venous thromboembolism over 30 days

Time: 30 days

Description: Frequency (%) of arterial or venous thromboembolism

Measure: Frequency of arterial or venous thromboembolism over 90 days

Time: 90 days

Secondary Outcomes

Description: Frequency (%) of all-cause death, bleeding, and thromboembolic outcomes

Measure: Frequency of all-cause death, bleeding, and thromboembolic outcomes at 30 days

Time: 30 days

Description: Frequency (%) of all-cause death, bleeding, and thromboembolic outcomes

Measure: Frequency of all-cause death, bleeding, and thromboembolic outcomes at 90 days

Time: 90 days

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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MeSH

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