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.

NCT05224388 | Completed DMC

• 1 other identifier: BC-07991
• Study Type: observational
• Target: 813
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Possible risk factors for thrombo-embolic complications in COVID-19 patients

  Time of discharge or death

• Safety of increased dose of thromboprophylaxis in Covid-19 patients

  Time of discharge or death

Study Arms (4)

Critically ill, prophylactic dose regimen

Prophylaxis of deep vein trombosis in critically ill patients

Drug: Enoxaparin; Drug: Heparin

Critically ill, therapeutic dose regimen

Therapeutic anticoagulation for tromboembolic pathology in critically ill patients

Drug: Enoxaparin; Drug: Heparin

Covid, prophylactic dose regimen

Prophylaxis of deep vein trombosis in Covid patients

Drug: Enoxaparin; Drug: Heparin

Covid, therapeutic dose regimen

Therapeutic anticoagulation for tromboembolic pathology in Covid patients

Drug: Enoxaparin; Drug: Heparin

Interventions

Enoxaparin DRUG

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

Also known as: Clexane

Covid, prophylactic dose regimen; Covid, therapeutic dose regimen; Critically ill, prophylactic dose regimen; Critically ill, therapeutic dose regimen

Heparin DRUG

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

Covid, prophylactic dose regimen; Covid, therapeutic dose regimen; Critically ill, prophylactic dose regimen; Critically ill, therapeutic dose regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years or older
• Hospitalisation required
• ICU admission

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

COVID-19; Venous Thrombosis; Hemostatic Disorders; Critical Illness

Interventions

Enoxaparin; Heparin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Harlinde Peperstraete, MD

  University Hospital, Ghent

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 4, 2022
• Study Start: January 1, 2020
• Primary Completion: August 31, 2021
• Study Completion: September 15, 2022
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

BE (1)