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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05224388

Enrollment

813

Registered

2022-02-04

Start date

2020-01-01

Completion date

2022-09-15

Last updated

2023-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGEnoxaparin

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

DRUGHeparin

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026