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.

NCT ID: NCT05224388

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 813 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2022-09-15

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Critically ill, prophylactic dose regimen

Prophylaxis of deep vein trombosis in critically ill patients

Enoxaparin

Intervention Type: DRUG

Use of enoxaparin in either prophylactic dose regimen or therapeutic dose regimen

Heparin

Intervention Type: DRUG

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

Enoxaparin

Intervention Type: DRUG

Use of enoxaparin in either prophylactic dose regimen or therapeutic dose regimen

Heparin

Intervention Type: DRUG

Use of heparin in either prophylactic dose regimen or therapeutic dose regimen

Covid, prophylactic dose regimen

Prophylaxis of deep vein trombosis in Covid patients

Enoxaparin

Intervention Type: DRUG

Use of enoxaparin in either prophylactic dose regimen or therapeutic dose regimen

Heparin

Intervention Type: DRUG

Use of heparin in either prophylactic dose regimen or therapeutic dose regimen

Covid, therapeutic dose regimen

Therapeutic anticoagulation for tromboembolic pathology in Covid patients

Enoxaparin

Intervention Type: DRUG

Use of enoxaparin in either prophylactic dose regimen or therapeutic dose regimen

Heparin

Intervention Type: DRUG

Use of heparin in either prophylactic dose regimen or therapeutic dose regimen

Interventions

Enoxaparin

Use of enoxaparin in either prophylactic dose regimen or therapeutic dose regimen

Intervention Type: DRUG

Heparin

Use of heparin in either prophylactic dose regimen or therapeutic dose regimen

Intervention Type: DRUG

Other Intervention Names

Clexane

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harlinde Peperstraete, MD

Role: STUDY_CHAIR

University Hospital, Ghent

Locations

Ghent University Hospital

Ghent, , Belgium

Countries

Belgium

Other Identifiers

BC-07991

Identifier Type: -

Identifier Source: org_study_id