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.

May 9, 2023 updated by: University Hospital, Ghent
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

813

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, 9000
        • Ghent University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Critically ill, prophylactic dose regimen
Prophylaxis of deep vein trombosis in critically ill patients
Drug: Enoxaparin
Use of enoxaparin in either prophylactic dose regimen or therapeutic dose regimen
Other Names:
  • Clexane
Drug: Heparin
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
Drug: Enoxaparin
Use of enoxaparin in either prophylactic dose regimen or therapeutic dose regimen
Other Names:
  • Clexane
Drug: Heparin
Use of heparin in either prophylactic dose regimen or therapeutic dose regimen
Covid, prophylactic dose regimen
Prophylaxis of deep vein trombosis in Covid patients
Drug: Enoxaparin
Use of enoxaparin in either prophylactic dose regimen or therapeutic dose regimen
Other Names:
  • Clexane
Drug: Heparin
Use of heparin in either prophylactic dose regimen or therapeutic dose regimen
Covid, therapeutic dose regimen
Therapeutic anticoagulation for tromboembolic pathology in Covid patients
Drug: Enoxaparin
Use of enoxaparin in either prophylactic dose regimen or therapeutic dose regimen
Other Names:
  • Clexane
Drug: Heparin
Use of heparin in either prophylactic dose regimen or therapeutic dose regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 36 hours
36 hours after start of the intervention drug (enoxaparin or heparin) the antiXa level is measured
36 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Study Chair: Harlinde Peperstraete, MD, University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

September 15, 2022

Study Registration Dates

First Submitted

February 3, 2022

First Submitted That Met QC Criteria

February 3, 2022

First Posted (Actual)

February 4, 2022

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC-07991

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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