Covid 19 Research using Clinical Trials (Home Page)
Report for D013927: Thrombosis NIH
(Synonyms: Thrombosi, Thrombosis)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (14)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug392 | Echo-Doppler Wiki | 0.33 |
| drug1121 | TEM-tPA Wiki | 0.33 |
| drug484 | Heparin Infusion Wiki | 0.33 |
| drug448 | Fondaparinux Wiki | 0.33 |
| drug383 | Duplex ultrasound and Computed Tomography Angiography Wiki | 0.33 |
| drug409 | Enoxaparin Prophylactic Dose Wiki | 0.33 |
| drug376 | Doppler Echo Wiki | 0.33 |
| drug408 | Enoxaparin Prefilled Syringe [Lovenox] Wiki | 0.33 |
| drug485 | Heparin SC Wiki | 0.33 |
| drug1165 | Tirofiban Injection Wiki | 0.33 |
| drug410 | Enoxaparin/Lovenox Intermediate Dose Wiki | 0.33 |
| drug38 | Acetylsalicylic acid Wiki | 0.33 |
| drug282 | Clopidogrel Wiki | 0.33 |
| drug407 | Enoxaparin Wiki | 0.17 |
Correlated MeSH Terms (12)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D020246 | Venous Thrombosis NIH | 0.75 |
| D004617 | Embolism NIH | 0.60 |
| D016769 | Embolism and Thrombosis NIH | 0.58 |
| D013923 | Thromboembolism NIH | 0.45 |
| D011655 | Pulmonary Embolism NIH | 0.38 |
| D054556 | Venous Thromboembolism NIH | 0.38 |
| D016638 | Critical Illness NIH | 0.14 |
| D011024 | Pneumonia, Viral NIH | 0.10 |
| D011014 | Pneumonia NIH | 0.05 |
| D014777 | Virus Diseases NIH | 0.05 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.04 |
| D018352 | Coronavirus Infections NIH | 0.03 |
Correlated HPO Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002625 | Deep venous thrombosis HPO | 0.75 |
| HP:0001907 | Thromboembolism HPO | 0.59 |
| HP:0002204 | Pulmonary embolism HPO | 0.38 |
| HP:0002090 | Pneumonia HPO | 0.05 |
There are 9 clinical trials
Clinical Trials
1 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 Infection Viral Thromboses, Venous Drug: Enoxaparin Prefilled Syringe [Lovenox] MeSH:Thrombosis Venous Thrombosis Virus Diseases
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
2 Assessment of Endothelial and Haemostatic Changes During Severe SARS-CoV-2 Infection
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 30Secondary 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 doseOther 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 hospitalizedDescription: 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 30Description: 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 30The 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 Covid-19 Endothelial Dysfunction Thrombosis 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 hoursSecondary 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 hoursDescription: 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 hoursDescription: 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 hoursDescription: 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 hoursDescription: 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 hoursDescription: 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 hoursDescription: 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 hours3 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 Deep Vein Thrombosis 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
4 Evaluation of TEM-tPA (Thromboelastometry With tPA) to Detect Covid-19 Patients at High Risk of 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 0Description: 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 7The 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 Thrombosis Covid-19 SARS-CoV 2 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 0Description: 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 3Description: 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 6Description: 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 9Description: 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 12Description: 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 15Description: 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 155 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 COVID-19 Venous Thromboses Arterial Thrombosis Drug: Enoxaparin Prophylactic Dose Drug: Heparin Infusion Drug: Heparin SC 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
6 Platelet Inhibition With GP IIb/IIIa Inhibitor in Critically Ill Patients With Coronavirus Disease 2019 (COVID-19). A Compassionate Use Protocol
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 daysSecondary 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 daysDescription: Length of stay measured in days.
Measure: ICU Length of Stay Time: Discharge from ICU or 30 daysDescription: 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 daysDescription: 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 daysDescription: Length of stay measured in days.
Measure: Hospital Length of Stay Time: Discharge from hospital or 30 daysThis 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 Pneumonia, Viral Corona Virus Infection Respiratory Failure Embolism and Thrombosis Drug: Tirofiban Injection Drug: Clopidogrel Drug: Acetylsalicylic acid 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
7 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
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 initiationDescription: 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 initiationDescription: 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 initiationSecondary 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 administrationDescription: 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 initiationDescription: 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 initiationDescription: 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 initiationDescription: 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 initiationDescription: 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 initiationDescription: 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 initiationDescription: 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 administrationWorldwide 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 COVID Thrombosis Pulmonary Embolism Deep Vein Thrombosis Drug: Enoxaparin 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
8 Risk of Venous Thromboembolism in Critically Ill Patients With Severe COVID-19
Primary Outcomes
Description: Risk of deep vein thrombosis or pulmonary embolism or venous thromboembolism-related death
Measure: Venous thromboembolism Time: 28 daysSecondary Outcomes
Description: Risk of major bleeding defined by the ISTH
Measure: Major bleeding Time: 28 daysDescription: 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 daysDescription: Risk of Venous Thromboembolism and Major Bleeding
Measure: Net Clinical Benefit Time: 28 days and 2 monthsDescription: 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 daysDescription: Risk of arterial thrombosis at any sites
Measure: Arterial Thrombosis Time: 28 daysDescription: Risk of all-cause mortality
Measure: All-Cause Mortality Time: 28 days and 2 monthsDescription: 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 daysSevere 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 COVID-19 Critical Illness Venous Thromboembolism Venous Thromboses Venous Thromboses, Deep Venous Thrombosis Pulmonary Pulmonary Embolism Pulmonary Embolism and Thrombosis Sars-CoV2 SARS-CoV Infection 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
9 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
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 daysSecondary Outcomes
Description: Deaths from all causes during the follow-up
Measure: Deaths Time: 7 daysCoronavirus 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 COVID Embolism and Thrombosis Pneumonia, Viral 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
HPO Nodes
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