CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


HP:0001907: ThromboembolismHPO

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (29)


Name (Synonyms) Correlation
drug3510 venous ultrasound Wiki 0.34
drug688 Clopidogrel Wiki 0.34
drug1012 Enoxaparin/Lovenox Intermediate Dose Wiki 0.24
drug27 2019-nCoV IgG/IgM Rapid Test Cassette Wiki 0.24
drug2923 Tirofiban Injection Wiki 0.24
drug3476 standard protocol Wiki 0.24
drug918 Dose of Tinzaparin or Dalteparin Wiki 0.24
drug2275 Public space exposure Wiki 0.24
drug936 Duplex ultrasound and Computed Tomography Angiography Wiki 0.24
drug671 Ciclesonide Metered Dose Inhaler [Alvesco] Wiki 0.24
drug139 Acetylsalicylic acid Wiki 0.24
drug1010 Enoxaparin Prophylactic Dose Wiki 0.24
drug2829 Taking blood samples for analyzing progesterone levels Wiki 0.24
drug1239 Heparin Infusion Wiki 0.24
drug881 Diagnostic examination for venous thromboembolism Wiki 0.24
drug3496 thromboprophylaxis with low-molecular-weight heparin or fondaparinux Wiki 0.24
drug1240 Heparin SC Wiki 0.24
drug3010 Unfractionated heparin SC Wiki 0.24
drug1133 Fondaparinux Wiki 0.24
drug3495 thromboprofylaxis protocol Wiki 0.24
drug3008 Unfractionated Heparin IV Wiki 0.24
drug2227 Prevalence of COVID-19 Wiki 0.24
drug1005 Enoxaparin 1 mg/kg Wiki 0.24
drug967 Echo-Doppler Wiki 0.24
drug3206 blood sample Wiki 0.20
drug1006 Enoxaparin 40 Mg/0.4 mL Injectable Solution Wiki 0.17
drug2898 Therapeutic anticoagulation Wiki 0.17
drug1004 Enoxaparin Wiki 0.07
drug1284 Hydroxychloroquine Wiki 0.02

Correlated MeSH Terms (17)


Name (Synonyms) Correlation
D013923 Thromboembolism NIH 0.91
D054556 Venous Thromboembolism NIH 0.64
D013927 Thrombosis NIH 0.48
D016769 Embolism and Thrombosis NIH 0.42
D004617 Embolism NIH 0.39
D020246 Venous Thrombosis NIH 0.38
D011655 Pulmonary Embolism NIH 0.34
D054058 Acute Coronary Syndrome NIH 0.11
D009205 Myocarditis NIH 0.09
D009203 Myocardial Ischemia NIH 0.07
D020141 Hemostatic Disorders NIH 0.06
D001778 Blood Coagulation Disorders NIH 0.06
D011024 Pneumonia, Viral NIH 0.06
D011014 Pneumonia NIH 0.05
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04
D016638 Critical Illness NIH 0.03

Correlated HPO Terms (6)


Name (Synonyms) Correlation
HP:0002625 Deep venous thrombosis HPO 0.38
HP:0002204 Pulmonary embolism HPO 0.34
HP:0012819 Myocarditis HPO 0.09
HP:0001658 Myocardial infarction HPO 0.07
HP:0001928 Abnormality of coagulation HPO 0.06
HP:0002090 Pneumonia HPO 0.05

There are 17 clinical trials

Clinical Trials


1 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 COVID Acute Coronary Syndrome Myocardial Infarction Myocarditis Venous Thromboembolism Deep Vein Thrombosis 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

2 Increased Risk of Venous Thromboembolism and Higher Hypercoagulable State in Patients Recovered in Intensive Care Unit and in Medical Ward for Coronavirus Disease 2019 (COVID-19)

The aim of this study is to verify if patients admitted to hospital in a medical division and in the intensive care unit for a COVID-19 infection are at higher risk of developing a VTE complication and if they actually present an increased hypercoagulable state.

NCT04359212 COVID-19 Disease Thromboembolism, Venous Drug: thromboprophylaxis with low-molecular-weight heparin or fondaparinux
MeSH:Thromboembolism Venous Thromboembolism
HPO:Thromboembolism

Primary Outcomes

Description: the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism

Measure: the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism

Time: 28 days

Secondary Outcomes

Description: the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism plus the asymptomatic incidentally detected pulmonary embolism

Measure: the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism plus the asymptomatic incidentally detected pulmonary embolism

Time: 28 days

3 Thrombo Embolic Events in Critical Care Patients With Covid-19 Serious Acute Pneumopathy

The understanding of haemostasis and inflammation cross-talk has gained considerable knowledge during the past decade in the field of arterial and venous thrombosis. Complex and delicately balanced interaction between coagulation and inflammation involve all cellular and humoral components. Elements of the coagulation system such as activated thrombin, fibrinogen or factor Xa may increase inflammation by promoting the production of pro-inflammatory cytokines, chemokines, growth factors and adhesion molecules that lead to a procoagulant state amplifying the pathological process. Recent evidence supports inflammation as a common pathogenic contributor to both arterial and venous thrombosis, giving rise to the concept of inflammation-induced thrombosis. Patients with infection of COVID-19 and severe pneumoniae seem to have higher risk of thromboembolism. Very few data are available regarding the biological disorders of coagulation in these patients. Th purpose of this project is to analyze hemostasis and coagulation of patients with infection of COVID-19 and severe pneumonia.

NCT04366752 COVID-19 Pneumonia ARDS Hemostasis Coagulation Other: venous ultrasound Other: blood sample
MeSH:Pneumonia Thromboembolism
HPO:Pneumonia Thromboembolism

Primary Outcomes

Description: The reference range for the thrombin time is usually less than 20 seconds (ie, 15-19 seconds)

Measure: Variation of thrombin time (in secondes) in Covid-19 patients with pneumonia admitted in ICU.

Time: up to 6 weeks

Description: Variation of factor V concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.

Measure: Variation of factor V concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.

Time: up to 6 weeks

Description: Variation of factor II concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.

Measure: Variation of factor II concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.

Time: up to 6 weeks

Description: Variation of concentration of fibrin and fibrinogen degradation products (≥ 10 µgm/mL) in Covid-19 patients with pneumonia admitted in ICU.

Measure: Variation of concentration of fibrin and fibrinogen degradation products (≥ 10 µgm/mL) in Covid-19 patients with pneumonia admitted in ICU.

Time: up to 6 weeks

4 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

5 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 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

6 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 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

7 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 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

8 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 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 Thrombo Embolic Events in Hospitalized Patients With Covid-19 Serious Acute Pneumopathy

The understanding of haemostasis and inflammation cross-talk has gained considerable knowledge during the past decade in the field of arterial and venous thrombosis. Complex and delicately balanced interaction between coagulation and inflammation involve all cellular and humoral components. Elements of the coagulation system such as activated thrombin, fibrinogen or factor Xa may increase inflammation by promoting the production of proinflammatory cytokines, chemokines, growth factors and adhesion molecules that lead to a procoagulant state amplifying the pathological process. Recent evidence supports inflammation as a common pathogenic contributor to both arterial and venous thrombosis, giving rise to the concept of inflammation induced thrombosis. Patients with infection of COVID-19 and severe pneumoniae seem to have higher risk of thromboembolism. The purpose of this project is to analyze hemostasis and coagulation of every hospitalized patient with infection of COVID-19. Blood sample for coagulation and hemostasis analysis will be collected on every patient hospitalized in Amiens hospital for COVID-19 infection. Thrombin time, factors V and II, fibrin/fibrinogen degradation products, antithrombin will be assessed every week. Anticardiolipin, anti-beta2 glycoprotein I and anti-annexin A2 antibodies IgG and IgM at day of admission and at fourth week after admission will be assessed. SARS-CoV2 viral load and serodiagnosis will be performed at the same time. At the same time venous ultrasound to diagnose thrombosis will be performed.

NCT04377490 COVID-19 Hemostasis Coagulation Other: venous ultrasound Biological: blood sample
MeSH:Thromboembolism
HPO:Thromboembolism

Primary Outcomes

Description: Variation of thrombin time (in secondes) in Hospitalized Covid-19 patients. The reference range for the thrombin time is usually less than 20 seconds (ie, 15-19 seconds)

Measure: Variation of thrombin time (in secondes) in Hospitalized Covid-19 patients

Time: up to 6 weeks

Description: Variation of factor V concentration (U/dL) in Hospitalized Covid-19 patients.

Measure: Variation of factor V concentration (U/dL) in Hospitalized Covid-19 patients.

Time: up to 6 weeks

Description: Variation of factor II concentration (U/dL) in Hospitalized Covid-19 patients

Measure: Variation of factor II concentration (U/dL) in Hospitalized Covid-19 patients

Time: up to 6 weeks

Description: Variation of concentration of fibrin and fibrinogen degradation products (≥ 10 µgm/mL) in Hospitalized Covid-19 patients.

Measure: Variation of concentration of fibrin and fibrinogen degradation products (≥ 10 µgm/mL) in Hospitalized Covid-19 patients.

Time: up to 6 weeks

10 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 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

11 Impact of Implementation of an Intensified Thromboprofylaxis Protocol in in Critically Ill ICU Patients With COVID-19: a Longitudinal Controlled Before-after Study

The aim of this study is to investigate and compare the mortality, the incidence of DVT and the incidence of kidney and liver failure in patients admitted to the ICU before and after the implementation of an intensified thromboprofylaxis protocol on 31st of March 2020. Patients in the before group are admitted at the ICU from 13/3/2020-30/3/2020 and patients in the after group are admitted to the ICU from 31/3 until 20/4/2020.

NCT04394000 COVID19 Thromboembolism Other: thromboprofylaxis protocol Other: standard protocol
MeSH:Thromboembolism
HPO:Thromboembolism

Primary Outcomes

Description: mortality was assessed in all COVID 19 patients admitted to the ICU

Measure: 2 week mortality

Time: 2 weeks after admission at ICU

Secondary Outcomes

Description: the incidence of venous thromboembolism was evaluated in all COVID 19 patients admitted to the ICU

Measure: incidence of venous thromboembolism

Time: during ICU stay up till 3th of May 2020

Description: mortality was assessed in all COVID 19 patients admitted to the ICU

Measure: 1 week mortality

Time: 1 week after admission at ICU

Description: mortality was assessed in all COVID 19 patients admitted to the ICU

Measure: 3 week mortality

Time: 3 weeks after admission at ICU

Description: mortality was assessed in all COVID 19 patients admitted to the ICU

Measure: 1 month mortality

Time: 1 month after admission at ICU

Description: incidence of acute kidney failure in all COVID 19 patients admitted to the ICU

Measure: incidence of kidney failure

Time: during ICU stay up till 3th of May 2020

Description: incidence of continuous renal replacement therapy (CRRT) in all COVID 19 patients admitted to the ICU

Measure: incidence of continuous renal replacement therapy (CRRT)

Time: during ICU stay up till 3th of May 2020

Description: evaluation of the lowest P/F ratio in all COVID 19 patients admitted to the ICU

Measure: lowest PaO2/FiO2 (P/F) ratio

Time: during ICU stay up till 3th of May 2020

Description: evaluation of the highest SOFA score in all COVID 19 patients admitted to the ICU

Measure: highest Sequential Organ Failure Assessment (SOFA) score

Time: during ICU stay up till 3th of May 2020

Description: evaluation of the length of stay in ICU and hospital of all COVID 19 patients admitted to the ICU

Measure: length of stay

Time: during ICU and hospital stay up till 3th of May 2020

Description: evaluation of the highest bilirubine level in all COVID 19 patients admitted to the ICU

Measure: highest bilirubin

Time: during ICU stay up till 3th of May 2020

Description: evaluation of the highest AST level in all COVID 19 patients admitted to the ICU

Measure: highest ( AST

Time: during ICU stay up till 3th of May 2020

Description: evaluation of the highest ALT level in all COVID 19 patients admitted to the ICU

Measure: highest Aspartaat-Amino-Transferase (ALT)

Time: during ICU stay up till 3th of May 2020

12 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 COVID-19 Venous Thromboembolism Pulmonary Embolism Deep Vein Thrombosis SARS-CoV 2 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

13 Incidence of Thromboembolic Events and Prognosis of COVID-19 Patients Hospitalized in Intensive Care Units in France

The main objective of this study is to describe the incidence of thromboembolic events in a population of patients hospitalized in intensive care units in France for severe COVID-19. The secondary objective of this study is to describe the evolution of hemostasis parameters during the first two weeks of intensive care hospitalization and to evaluate the influence of different anticoagulation regimens on these parameters and on the incidence of thromboembolic events

NCT04405869 Pulmonary Thromboembolism
MeSH:Pulmonary Embolism Thromboembolism
HPO:Pulmonary embolism Thromboembolism

Primary Outcomes

Measure: Analysis of incidence of thromboembolic events in patients with Sars-CoV-2

Time: 1 month

14 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 COVID-19 Venous Thromboembolism Arterial Thrombosis Drug: Unfractionated Heparin IV Drug: Enoxaparin 1 mg/kg Drug: Clopidogrel Drug: Unfractionated heparin SC 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

15 Patient Characteristics, Outcome and Thromboembolic Events Among Adult Critically Ill COVID-19 Patients With Different Anticoagulant Regimes at One of the Biggest Emergency Hospitals in Northern Europe, Sweden

The aims of the study are to to associate anticoagulation (AC) regime with outcome in critically ill patients with Covid-19. This will be done by describe baseline characteristics and comorbidities before hospital admission, level of organ support and dose of AC treatment and associate this with 28 days survival, survival outside ICU, thromboembolic event and bleeding complications.

NCT04412304 Covid-19 Thromboembolic Events Bleeding Drug: Dose of Tinzaparin or Dalteparin
MeSH:Thromboembolism
HPO:Thromboembolism

Primary Outcomes

Description: 28-days ICU mortality from admission to the ICU. Discontinue of ICU-care to palliative care counts as death.

Measure: 28-days ICU mortality

Time: 28 days from ICU-admission

Secondary Outcomes

Description: Thromboembolic events are defined as pulmonary emboli (PE), deep venous thrombus (DVT), ischemic stroke and other peripheral arterial emboli. PE is defined as PE verified by computer tomography or by findings of acute strain of the right heart on echocardiography combined with a clinical interpretation of the patients deteriorating as a probable PE stated in the medical records. DVT is defined as DVT verified with ultrasound. Ischemic stroke is defined as ischemic stroke verified by computer tomography. Peripheral arterial emboli are defined as peripheral arterial emboli verified by computer tomography.

Measure: Incidence of thromboembolic events

Time: 28 days from ICU-admission

Description: The event of bleeding will be defined by WHO modified bleeding scale as 1-4.

Measure: Incidence of bleeding events

Time: 28 days from ICU-admission

Description: ICU-free days alive during 28 days from ICU-admission. Counts as 0 days if discharged to ward for palliative treatment.

Measure: ICU-free days alive from ICU-admission.

Time: 28 days from ICU-admission

Other Outcomes

Description: D-dimer every day it is measured during first 28 days from ICU-admission.

Measure: D-dimer levels in the three groups groups

Time: 28 days from ICU-admission

16 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 Corona Virus Infection 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

17 Utilização da Enoxaparina em Dose Anticoagulante em Pacientes Hospitalizados Com síndrome respiratória Aguda Grave Por COVID-19

Published papers evaluating coagulopathy on COVID-19 patients indicate a higher incidence of thromboembolic events, sometimes, as high as 20%. Such events increase ICU admissions and are associated with death. Considering the importance of thromboembolic events concurring to deteriorate clinical state, we propose to conduct a parallel pragmatic open-label randomized controlled trial to determine the effect of therapeutic anticoagulation compared to standard care in hospitalized patients with COVID-19 and with low oxygen saturation.

NCT04444700 COVID Coronavirus Infection Severe Acute Respiratory Syndrome Thromboe Thromboembolism, Venous Anticoagulants and Bleeding Disorders Drug: Therapeutic anticoagulation
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Thromboembolism Hemostatic Disorders Venous Thromboembolism Blood Coagulation Disorders
HPO:Abnormality of coagulation Abnormality of the coagulation cascade Thromboembolism

Primary Outcomes

Description: Composite outcome of ICU admission (yes/no), non-invasive positive pressure ventilation (yes/no), invasive mechanical ventilation (yes/no), or all-cause death (yes/no) up to 28 days.

Measure: Composite main outcome

Time: up to 28 days

Secondary Outcomes

Description: All-cause death

Measure: All-cause death

Time: 28 days

Description: Composite outcome of ICU admission or all-cause death

Measure: Composite outcome of ICU admission or all-cause death

Time: 28 days

Description: Major bleeding

Measure: Major bleeding

Time: 28 days

Description: Red Blood Cell transfusion (greater than or equal to 1 unit)

Measure: Number of participants who received red blood cell transfusion

Time: 28 days

Description: Transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipitate and/or fibrinogen concentrate

Measure: Number of participants with transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipitate and/or fibrinogen concentrate.

Time: 28 days

Description: Hospital-free days alive up to day 28

Measure: Number of hospital-free days alive up to day 28

Time: 28 days

Description: ICU-free days alive up to day 28

Measure: Number of ICU-free days alive up to day 28

Time: 28 days

Description: Ventilator-free days alive up to day 28

Measure: Number of ventilator-free days alive up to day 28

Time: 28 days

Description: Venous thromboembolism

Measure: Number of participants with venous thromboembolism

Time: 28 days

Description: Arterial thromboembolism

Measure: Number of participants with arterial thromboembolism

Time: 28 days

Description: Heparin induced thrombocytopenia

Measure: Number of participants with heparin induced thrombocytopenia

Time: 28 days


HPO Nodes