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.

Ghent University Hospital (UZ)

Status: Completed

Conditions: COVID-19; Critical Illness; Deep Vein Thrombosis; Anticoagulants and Bleeding Disorders

Treatments: Drug: Enoxaparin; Drug: Heparin

Study type: Observational

Funder types: Other

Identifiers

NCT05224388

BC-07991

Details and patient eligibility

About

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.

Full 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.

Enrollment: 813 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

813 participants in 4 patient groups

Critically ill, prophylactic dose regimen

Description:

Prophylaxis of deep vein trombosis in critically ill patients

Treatment:

Drug: Heparin

Drug: Enoxaparin

Critically ill, therapeutic dose regimen

Description:

Therapeutic anticoagulation for tromboembolic pathology in critically ill patients

Treatment:

Drug: Heparin

Drug: Enoxaparin

Covid, prophylactic dose regimen

Description:

Prophylaxis of deep vein trombosis in Covid patients

Treatment:

Drug: Heparin

Drug: Enoxaparin

Covid, therapeutic dose regimen

Description:

Therapeutic anticoagulation for tromboembolic pathology in Covid patients

Treatment:

Drug: Heparin

Drug: Enoxaparin