CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D013923: Thromboembolism NIH

(Synonyms: Thromboembo, Thromboembolism)

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


Correlated Drug Terms (16)


Name (Synonyms) Correlation
drug479 Enoxaparin/Lovenox Intermediate Dose Wiki 0.33
drug569 Heparin Infusion Wiki 0.33
drug1663 standard protocol Wiki 0.33
drug446 Duplex ultrasound and Computed Tomography Angiography Wiki 0.33
drug1447 Unfractionated heparin SC Wiki 0.33
drug1445 Unfractionated Heparin IV Wiki 0.33
drug426 Diagnostic examination for venous thromboembolism Wiki 0.33
drug570 Heparin SC Wiki 0.33
drug1674 thromboprofylaxis protocol Wiki 0.33
drug474 Enoxaparin 40 Mg/0.4 mL Injectable Solution Wiki 0.33
drug1675 thromboprophylaxis with low-molecular-weight heparin or fondaparinux Wiki 0.33
drug473 Enoxaparin 1 mg/kg Wiki 0.33
drug477 Enoxaparin Prophylactic Dose Wiki 0.33
drug441 Dose of Tinzaparin or Dalteparin Wiki 0.33
drug331 Clopidogrel Wiki 0.24
drug472 Enoxaparin Wiki 0.15

Correlated MeSH Terms (9)


Name (Synonyms) Correlation
D054556 Venous Thromboembolism NIH 0.75
D011655 Pulmonary Embolism NIH 0.50
D020246 Venous Thrombosis NIH 0.50
D013927 Thrombosis NIH 0.46
D004617 Embolism NIH 0.35
D016769 Embolism and Thrombosis NIH 0.19
D016638 Critical Illness NIH 0.07
D045169 Severe Acute Respiratory Syndrome NIH 0.02
D018352 Coronavirus Infections NIH 0.02

Correlated HPO Terms (3)


Name (Synonyms) Correlation
HP:0001907 Thromboembolism HPO 0.59
HP:0002625 Deep venous thrombosis HPO 0.45
HP:0002204 Pulmonary embolism HPO 0.38

There are 9 clinical trials

Clinical Trials


1 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

2 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

3 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

4 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

5 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

6 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

7 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

8 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

9 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


HPO Nodes