Clinical trial NCT05224388: 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.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Deep Vein Thrombosis
Anticoagulants and Bleeding Disorders
Critical Illness
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 813
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: 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
timeFrame: 36 hours
Secondary outcomes:
measure: Possible risk factors for thrombo-embolic complications in COVID-19 patients
timeFrame: Time of discharge or death
measure: Safety of increased dose of thromboprophylaxis in Covid-19 patients
timeFrame: Time of discharge or death
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Harlinde Peperstraete, MD
role: STUDY_CHAIR
References: