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.

Sponsor

University Hospital, Ghent (Other)

Overall Status

Recruiting

CT.gov ID

NCT05224388

Collaborator

(none)

800

Enrollment

Location

26.9

Anticipated Duration (Months)

29.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Deep Vein Thrombosis Anticoagulants and Bleeding Disorders Critical Illness	Drug: Enoxaparin Drug: Heparin

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 Design

Study Type:

Observational

Anticipated Enrollment :

800 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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.

Actual Study Start Date :

Jan 1, 2020

Actual Primary Completion Date :

Aug 31, 2021

Anticipated Study Completion Date :

Mar 30, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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