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.

COVID-19 Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05224388
• Other study ID #: BC-07991
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: September 15, 2022

Study information

• Verified date: May 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 813
• Est. completion date: September 15, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulants and Bleeding Disorders
• Blood Coagulation Disorders
• COVID-19
• Critical Illness
• Deep Vein Thrombosis
• Hemostatic Disorders
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Enoxaparin
Use of enoxaparin in either prophylactic dose regimen or therapeutic dose regimen
• Heparin
Use of heparin in either prophylactic dose regimen or therapeutic dose regimen

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Gent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

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