Evaluating Dose Regimen of Intravenous Unfractionated Heparin and Low Molecular Weight Heparin in Critical Ill Patients Versus Critical Ill COVID-19 Patients Using Anti-Xa Levels.

To see whether our increased dosing regimen of unfractionated heparin (UF) and low molecular weight heparin (LMWH) in COVID-19 patients was effective at preventing thrombo-embolic complications. We did regular anti-Xa tests to optimise the dose of our thromboprophylaxis. Furthermore, we want to examine the time it takes to reach adequate anti-Xa levels, to determine additional risk factors and do a subgroup analysis. Lastly, we will study if there are possible complications of our thromboprophylactic therapy.

Study Overview

• Status: Completed
• Conditions: COVID-19; Critical Illness; Deep Vein Thrombosis; Anticoagulants and Bleeding Disorders
• Intervention / Treatment: Drug: Enoxaparin; Drug: Heparin

Detailed Description

COVID-19 took the world by storm with its fast spread, high number of infected patients and its potential to range from mild illness to very severe respiratory distress. This pandemic is currently the focus of a lot of research, however there are still a lot of unknowns regarding COVID-19. Current literature shows that COVID-19 patients have an increased risk for thrombo-embolic events which is why patients at the Ghent university hospital get increased dose of thrombo-prophylactic therapy. Patients were also screened for presence of deep venous thrombosis using ultrasound.

Anti-Xa is a test in which the we determine the activity of the antithrombine-heparine complex on factor Xa. Using this test allowed us to measure the effect of our UF of LWMH and adjust the dose if needed.

At this moment It is still unclear how high the prevalence of thromboembolic events in this group of patients is and whether our thromboprophylaxic therapy prevents this. We also looked into the time it took for anti-Xa to reach adequate levels in our dosing regimen. Furthermore, current risk factors for thromboembolic complications in COVID-19 patients are still unclear. We compared the results of the COVID-19 patients to a group of critical ill patients without COVID-19.

• Study Type: Observational
• Enrollment (Actual): 813

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

COVID-19 patients and other critical ill patients, during their stay in the intensive care unit of the Ghent University Hospital.

Description

Inclusion Criteria:

• 18 years or older
• Hospitalisation required
• ICU admission

Exclusion Criteria:

• Coagulopathies prior to COVID 19 infection (known thromboembolism in the last 6 months i.e. deep venous thrombosis, pulmonary embolism, …)
• Therapeutic anticoagulation on moment of ICU admission
• Major trauma
• Major bleeding
• Cerebro vascular accident or neuro trauma in the last month

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Critically ill, prophylactic dose regimen; Prophylaxis of deep vein trombosis in critically ill patients	Drug: Enoxaparin; Use of enoxaparin in either prophylactic dose regimen or therapeutic dose regimen; Other Names: Clexane; Drug: Heparin; Use of heparin in either prophylactic dose regimen or therapeutic dose regimen
Critically ill, therapeutic dose regimen; Therapeutic anticoagulation for tromboembolic pathology in critically ill patients	Drug: Enoxaparin; Use of enoxaparin in either prophylactic dose regimen or therapeutic dose regimen; Other Names: Clexane; Drug: Heparin; Use of heparin in either prophylactic dose regimen or therapeutic dose regimen
Covid, prophylactic dose regimen; Prophylaxis of deep vein trombosis in Covid patients	Drug: Enoxaparin; Use of enoxaparin in either prophylactic dose regimen or therapeutic dose regimen; Other Names: Clexane; Drug: Heparin; Use of heparin in either prophylactic dose regimen or therapeutic dose regimen
Covid, therapeutic dose regimen; Therapeutic anticoagulation for tromboembolic pathology in Covid patients	Drug: Enoxaparin; Use of enoxaparin in either prophylactic dose regimen or therapeutic dose regimen; Other Names: Clexane; Drug: Heparin; Use of heparin in either prophylactic dose regimen or therapeutic dose regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate dose regimen of UFH en LMWH for critically ill patients and Covid-19 patients in: - preventing thrombo-embolic complications - time to reach adequate prophylactic antiXa range	36 hours after start of the intervention drug (enoxaparin or heparin) the antiXa level is measured	36 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Possible risk factors for thrombo-embolic complications in COVID-19 patients	Risk factors are minor bleeding, major bleeding	Time of discharge or death
Safety of increased dose of thromboprophylaxis in Covid-19 patients	Special consideration of minor or major bleeding	Time of discharge or death

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Study Chair: Harlinde Peperstraete, MD, University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Hematologic Diseases; Hemorrhagic Disorders; Embolism and Thrombosis; COVID-19; Hemostatic Disorders; Blood Coagulation Disorders; Critical Illness; Thrombosis; Venous Thrombosis; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Enoxaparin
• Other Study ID Numbers: BC-07991

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No