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  • HP:0001907: Thromboembolism
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    HP:0001907: Thromboembolism

    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 (36)


    Name (Synonyms) Correlation
    drug5290 venous ultrasound Wiki 0.29
    drug1015 Clopidogrel Wiki 0.24
    drug5272 thromboprophylaxis with low-molecular-weight heparin or fondaparinux Wiki 0.21
    Name (Synonyms) Correlation
    drug1362 Dose of Tinzaparin or Dalteparin Wiki 0.21
    drug5239 standard protocol Wiki 0.21
    drug4571 Unfractionated Heparin IV Wiki 0.21
    drug2965 Online questionnaire and interviews Wiki 0.21
    drug3307 Plitidepsin 1.5 mg/day Wiki 0.21
    drug1389 Duplex ultrasound and Computed Tomography Angiography Wiki 0.21
    drug1363 Dose of tinzaparin or dalteparin Wiki 0.21
    drug1875 Heparin SC Wiki 0.21
    drug211 Acetylsalicylic acid Wiki 0.21
    drug3308 Plitidepsin 2.0 mg/day Wiki 0.21
    drug3309 Plitidepsin 2.5 mg/day Wiki 0.21
    drug3142 Peripheral venous ultrasound Wiki 0.21
    drug1445 Echo-Doppler Wiki 0.21
    drug1306 Diagnostic examination for venous thromboembolism Wiki 0.21
    drug5271 thromboprofylaxis protocol Wiki 0.21
    drug1707 Fondaparinux Wiki 0.21
    drug4573 Unfractionated heparin SC Wiki 0.21
    drug1512 Enoxaparin 1 mg/kg Wiki 0.21
    drug1874 Heparin Infusion Wiki 0.21
    drug1519 Enoxaparin/Lovenox Intermediate Dose Wiki 0.21
    drug4561 Ultrasonography Wiki 0.21
    drug943 Ceralasertib Wiki 0.21
    drug33 18F-DX600 PET/CT Wiki 0.21
    drug2302 Laboratory test positive for SARS-CoV-2 virus Wiki 0.21
    drug4423 Tirofiban Injection Wiki 0.21
    drug1517 Enoxaparin Prophylactic Dose Wiki 0.21
    drug3716 Rivaroxaban 10 MG Wiki 0.21
    drug1513 Enoxaparin 40 Mg/0.4 mL Injectable Solution Wiki 0.15
    drug4387 Therapeutic anticoagulation Wiki 0.15
    drug4859 blood sample Wiki 0.13
    drug2916 Observational Wiki 0.10
    drug1511 Enoxaparin Wiki 0.05
    drug2827 No intervention Wiki 0.04

    Correlated MeSH Terms (19)


    Name (Synonyms) Correlation
    D013923 Thromboembolism NIH 0.91
    D054556 Venous Thromboembolism NIH 0.63
    D013927 Thrombosis NIH 0.43
    Name (Synonyms) Correlation
    D016769 Embolism and Thrombosis NIH 0.42
    D004617 Embolism NIH 0.34
    D011655 Pulmonary Embolism NIH 0.31
    D020246 Venous Thrombosis NIH 0.30
    D009203 Myocardial Ischemia NIH 0.09
    D054058 Acute Coronary Syndrome NIH 0.09
    D009205 Myocarditis NIH 0.07
    D007238 Infarction NIH 0.06
    D020141 Hemostatic Disorders NIH 0.05
    D001778 Blood Coagulation Disorders NIH 0.05
    D011024 Pneumonia, Viral NIH 0.05
    D011014 Pneumonia NIH 0.04
    D045169 Severe Acute Respiratory Syndrome NIH 0.03
    D009369 Neoplasms, NIH 0.03
    D018352 Coronavirus Infections NIH 0.03
    D016638 Critical Illness NIH 0.03

    Correlated HPO Terms (7)


    Name (Synonyms) Correlation
    HP:0002204 Pulmonary embolism HPO 0.31
    HP:0002625 Deep venous thrombosis HPO 0.30
    HP:0001658 Myocardial infarction HPO 0.09
    Name (Synonyms) Correlation
    HP:0012819 Myocarditis HPO 0.07
    HP:0001928 Abnormality of coagulation HPO 0.05
    HP:0002090 Pneumonia HPO 0.04
    HP:0002664 Neoplasm HPO 0.03

    Clinical Trials

    Navigate: Correlations   HPO

    There are 23 clinical trials


    1 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: hospitalisation duration

    Description: Incidence of shock during hospitalisation

    Measure: Shock

    Time: hospitalisation duration

    Description: Number of day at hospital

    Measure: length of stay

    Time: hospitalisation duration

    Description: Setting up or not of mechanical ventilation

    Measure: Mechanical ventilation

    Time: hospitalisation duration

    Description: Administration or not of renal replacement therapy

    Measure: Renal replacement therapy

    Time: hospitalisation duration
    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
    Conditions
    1. COVID-19 Disease
    2. Thromboembolism, Venous
    Interventions
    1. 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
    Conditions
    1. COVID-19
    2. Pneumonia
    3. ARDS
    4. Hemostasis
    5. Coagulation
    Interventions
    1. Other: venous ultrasound
    2. 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
    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
    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
    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
    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
    Conditions
    1. COVID
    2. Thrombosis
    3. Pulmonary Embolism
    4. Deep Vein Thrombosis
    Interventions
    1. Drug: Enoxaparin
    2. Drug: Enoxaparin
    MeSH:Pulmonary Embolism Thrombosis Thromboembolism Emb 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
    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
    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
    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
    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
    Conditions
    1. COVID-19
    2. Hemostasis
    3. Coagulation
    Interventions
    1. Other: venous ultrasound
    2. 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
    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
    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
    Conditions
    1. COVID19
    2. Thromboembolism
    Interventions
    1. Other: thromboprofylaxis protocol
    2. 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
    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
    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
    Conditions
    1. 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
    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
    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
    Conditions
    1. Covid-19
    2. Thromboembolic Events
    3. Bleeding
    Interventions
    1. 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
    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
    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
    Conditions
    1. COVID
    2. Coronavirus Infection
    3. Severe Acute Respiratory S
    4. Severe Acute Respiratory Syndrome
    5. Thromboembolism, Venous
    6. Anticoagulants and Bleeding Disorders
    Interventions
    1. 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
    18 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
    19 Prevalence and Risk Factors for Venous Thromboembolic Events in Critically Ill Patients With SARS-CoV-2 Infection

    The purpose of the study is to assess the frequency of the occurrence of a venous thrombosis in patients with the new Coronavirus disease, who are admitted to the Intensive Care Unit for impending respiratory failure requiring intubation and mechanical ventilation. Furthermore, the investigators aim at identifying potential risk factors for thrombosis and death.

    NCT04567927
    Conditions
    1. SARS Virus
    Interventions
    1. Other: Ultrasonography
    MeSH:Thromboembolism
    HPO:Thromboembolism

    Primary Outcomes

    Description: Percent (%) of patients with a DVT

    Measure: Period prevalence of deep vein thrombosis (DVT)

    Time: From date of inclusion in the study until the date of development of a DVT, date of death from any cause, or date of discharge from the ICU, whichever came first, assessed up to 3 months
    20 COVID-19 and Venous Thromboembolism Risk

    Coronavirus disease 2019 (Covid-19) is now a leading cause of death among U.S. adults. In addition to profound respiratory and multi-organ failure, hypercoagulable states and venous thromboembolism (VTE) have been increasingly reported in patients with severe Covid-19. The aim of this study is evaluate the risk of VTE related to Covid-19 infection in a real-world community-based population.

    NCT04569344
    Conditions
    1. Venous Thromboembolism
    2. Covid19
    Interventions
    1. Other: Laboratory test positive for SARS-CoV-2 virus
    MeSH:Thromboembolism Venous Thromboembolism
    HPO:Thromboembolism

    Primary Outcomes

    Description: VTE will be defined as a clinical encounter with evidence of acute VTE, identified by diagnosis codes, +/- radiology procedure codes

    Measure: Acute venous thromboembolism (VTE)

    Time: From the date of first positive test for SARS-CoV-2 virus occuring after January 1, 2020, until death, disenrollment from the health system, or the end of the planned outcome assessment (March 31, 2021)

    Description: Death from any cause

    Measure: Death

    Time: From the date of first positive test for SARS-CoV-2 virus occuring after January 1, 2020, until disenrollment from the health system, or the end of the planned outcome assessment (March 31, 2021)
    21 Dosing of Thromboprophylaxis and Mortality in Critically Ill COVID-19 Patients - More Patients Included and 90-day Follow up

    The aim of the study is to associate dose of thromboprophylaxis with outcome in critically ill COVID-19 patients. This will be done by associating dose of thromboprophylaxis with 28-day mortality, survival outside ICU, thromboembolic event and bleeding complications.This was done in our earlier study for patients admitted in March and April (Clinicaltrials.gov NCT04412304 June 2 2020) but now we will include the patients admitted in May, June and half of July and we will ad the outcome of 90-day mortality.

    NCT04593654
    Conditions
    1. Covid19
    2. Thromboembolism
    Interventions
    1. Drug: Dose of tinzaparin or dalteparin
    MeSH:Thromboembolism
    HPO:Thromboembolism

    Primary Outcomes

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

    Measure: 28-day mortality

    Time: 28 days from ICU-admission

    Secondary Outcomes

    Description: Thromboembolic events are defined as pulmonary emboli (PE), deep venous thrombus (DVT) and ischemic stroke. 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.

    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

    Description: 90-day mortality from admission to ICU.

    Measure: 90-day mortality

    Time: 90 days from ICU-admission

    Other Outcomes

    Description: Median value of Fibrin-D-dimer

    Measure: Fibrin-D-dimer levels

    Time: 28 days from ICU-admission
    22 Thromboembolic Risk Screening in Patients With Cancer and COVID-19

    Study Rational Since December 2019, outbreak of COVID-19 caused by a novel virus SARS-Cov-2 has spread rapidly around the world and became a pandemic issue. First data report high mortality in severe patients with 30% death rate at 28 days. Exact proportions of the reasons of death are unclear: severe respiratory distress syndrome is mainly reported which can be related to massive cell destruction by the virus, bacterial surinfection, cardiomyopathy or pulmonary embolism. The exact proportion of all these causes is unknown and venous thromboembolism could be a major cause because of the massive inflammation reported during COVID-19. High levels of D-dimers and fibrin degradation products are associated with increased risk of mortality and some authors suggest a possible occurrence of venous thromboembolism (VTE) during COVID-19. Indeed, COVID-19 infected patients are likely at increased risk of VTE. In a multicenter retrospective cohort study from China, elevated D-dimers levels (>1g/L) were strongly associated with in-hospital death, even after multivariable adjustment. Also, interestingly,the prophylactic administration of anticoagulant treatment was associated with decreased mortality in a cohort of 449 patients, with a positive effect in patients with coagulopathy (sepsis-induced coagulopathy score ≥ 4) reducing the 28 days mortality rate (32.8% versus 52.4%, p=0.01). However the presence/prevalence of VTE disease is unknown in COVID-19 cancer patients with either mild or severe disease. Cancer patients are at a higher risk of VTE than general population (x6 times) and could be consequently at a further higher of VTE during COVID-19, in comparison with non-cancer patients. The exact rate of VTE and pulmonary embolism during COVID-19 was never evaluated, especially in cancer patients, and is of importance in order to understand if this disease needs appropriate prophylaxis against VTE. The largest series of cancer patients so far included 28 COVID-19 infected cancer patients: the rate of mortality was 28.6%. 78.6% of them needed oxygen therapy, 35.7% of them mechanical ventilation. Pulmonary embolism was suspected in some patients but not investigated due to the severity of the disease and renal insufficiency, reflecting the lack of data in this situation. The aim of the present study is to analyze the rate of symptomatic/occult VTE in a cohort of patients with cancer. Expected benefits Anticipated benefits of the research are the detection of VTE in order to treat it for the included patient. For all COVID-19 positive cancer patients it will enable to provide some guidelines and determine which patient are at risk for VTE and which will need ultrasound to detect occult VTE. Foreseeable risks Foreseeable risks for patients are non-significant because the additional procedures needed are ultrasound exam, and blood sample test. Methodology Retrospective and prospective (ambispective), multicentric study to evaluate the occurrence of venous thromboembolism during COVID-19 infection. Indeed, because the outbreak can end within the next 3-6 months, Investigators may not be able to answer the question if Investigators only focus on patients investigated prospectively. Investigators then decided to include patients from medical team who are already systemically screening patients with COVID-19 disease for VTE. Trial objectives Main objective To evaluate the rate of venous thromboembolism at 23 days during COVID-19 infection in cancer patients.

    NCT04616846
    Conditions
    1. Neoplasms Malignant
    2. Covid19
    3. Thromboembolism
    Interventions
    1. Diagnostic Test: Peripheral venous ultrasound
    MeSH:Neoplasms Thromboembolism
    HPO:Neoplasm Thromboembolism

    Primary Outcomes

    Description: Deep venous thrombosis and/or pulmonary embolism.

    Measure: Rate of venous thromboembolism

    Time: From Day 9 to Day 42

    Secondary Outcomes

    Description: Rate of hospitalization

    Measure: Hospitalization due to venous thromboembolism

    Time: Day 23

    Description: Time between the date of inclusion and the date of death for any reason.

    Measure: Overall Survival

    Time: Day 23

    Description: Time between the date of inclusion and the date of death for venous thromboembolism.

    Measure: Specific survival

    Time: Day 23

    Description: Common toxicity criteria from the NCI CTCAE V5.0

    Measure: Safety profile using the common toxicity criteria from the NCI CTCAE V5.0

    Time: Day 1 to Day 23

    Description: Khorana score (low risk (score=0), medium risk (score=1 ou 2) and high risk (score ≥ 3)

    Measure: Predictive factors for venous thromboembolism

    Time: Day 1 to Day 23

    Description: Caprini score (very low risk (score=0), low risk (score=1 or 2), medium risk (score=3 or 4)and high risk (score ≥ 5)

    Measure: Predictive factors for venous thromboembolism

    Time: Day 1 to Day 23

    Description: Common toxicity criteria from the NCI CTCAE V5.0

    Measure: rate of symptomatic venous thromboembolism between the COVID-19 negative and COVID-19 positive patients

    Time: Day 1 to Day 23
    23 Medically Ill Hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis With Rivaroxaban ThErapy: The MICHELLE Trial

    The Michelle trial is expected to provide high-quality evidence around the role of extended thromboprophylaxis in COVID-19 and will help guide medical decisions in clinical practice.

    NCT04662684
    Conditions
    1. Covid19
    2. Venous Thromboembolism
    Interventions
    1. Drug: Rivaroxaban 10 MG
    MeSH:Thrombosis Thromboembolism Venous Thromboembolism
    HPO:Thromboembolism

    Primary Outcomes

    Description: a composite efficacy endpoint of symptomatic VTE, VTE-related death, and/or VTE detected by mandatory bilateral lower limbs venous duplex scan and computed tomography pulmonary angiogram on day 35+/-4 post-hospital discharge

    Measure: Venous thromboembolism and VTE related-death

    Time: at day 35 +/- post hospital discharge

    Secondary Outcomes

    Description: Incidence of major bleeding according to ISTH criteria.

    Measure: Major bleeding

    Time: at day 35 +/- post hospital discharge

    Other Outcomes

    Description: A composite of myocardial infarction, stroke, arrhythmias, heart failure, venous thromboembolism (VTE), and all-cause death.

    Measure: A composite of myocardial infarction, stroke, arrhythmias, heart failure, venous thromboembolism (VTE), and all-cause death.

    Time: at day 35 +/- post hospital discharge

    Description: Days alive out of the hospital (DAOH) at 35 +/-4 days

    Measure: Days alive out of the hospital (DAOH) at 35 +/-4 days

    Time: at day 35 +/- post hospital discharge

    Description: plasma level of D-dimers in ng/mL

    Measure: D-dimer (Biomarker)

    Time: at day 35 +/- 4 post hospital discharge

    Description: plasma level of C Reactive Protein in μg/mL

    Measure: C reactive protein (Biomarker)

    Time: at day 35 +/- 4 post hospital discharge

    Description: plasma level of PAI-1 in units/mL

    Measure: PAI-1 (Biomarker)

    Time: at day 35 +/- 4 post hospital discharge

    Description: plasma level of TFPI in units/mL

    Measure: TFPI (Biomarker)

    Time: at day 35 +/- 4 post hospital discharge

    Description: plasma level of Thrombomodulin in nM/mL

    Measure: Thrombomodulin (Biomarker)

    Time: at day 35 +/- 4 post hospital discharge

    Description: plasma level of IL-6 in pg/mL

    Measure: IL-6 (Biomarker)

    Time: at day 35 +/- 4 post hospital discharge

    HPO Nodes


    Reports

    Data processed on December 13, 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.

    Drug Reports   MeSH Reports   HPO Reports  

    Interventions

    4,818 reports on interventions/drugs

    MeSH

    706 reports on MeSH terms

    HPO

    306 reports on HPO terms

    All Terms

    Alphabetical index of all Terms

    Google Colab

    Python example via Google Colab Notebook