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.

Completed

• Conditions: COVID-19; Critical Illness; Anticoagulants and Bleeding Disorders; Deep Vein Thrombosis
• Interventions: Drug: Enoxaparin; Drug: Heparin

• Registration Number: NCT05224388
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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.

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 Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-08-31
• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-03
• Study First Posted: 2022-02-04
• Study Completion: 2022-09-15
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 813

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Critically ill, prophylactic dose regimen	Enoxaparin	Prophylaxis of deep vein trombosis in critically ill patients
Critically ill, therapeutic dose regimen	Enoxaparin	Therapeutic anticoagulation for tromboembolic pathology in critically ill patients
Covid, prophylactic dose regimen	Enoxaparin	Prophylaxis of deep vein trombosis in Covid patients
Critically ill, prophylactic dose regimen	Heparin	Prophylaxis of deep vein trombosis in critically ill patients
Critically ill, therapeutic dose regimen	Heparin	Therapeutic anticoagulation for tromboembolic pathology in critically ill patients
Covid, prophylactic dose regimen	Heparin	Prophylaxis of deep vein trombosis in Covid patients
Covid, therapeutic dose regimen	Enoxaparin	Therapeutic anticoagulation for tromboembolic pathology in Covid patients
Covid, therapeutic dose regimen	Heparin	Therapeutic anticoagulation for tromboembolic pathology in Covid patients

Primary Outcome Measures

Name	Time	Method
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	36 hours after start of the intervention drug (enoxaparin or heparin) the antiXa level is measured

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Gent, Belgium