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 Overview
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Brief Summary
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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
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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.

Official Title
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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.

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

Intervention / Treatment
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* Drug: Enoxaparin
* Drug: Heparin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Critically ill, prophylactic dose regimen<br>Prophylaxis of deep vein trombosis in critically ill patients | Drug: Enoxaparin<br>* Use of enoxaparin in either prophylactic dose regimen or therapeutic dose regimen<br>* Other names: Clexane;Drug: Heparin<br>* Use of heparin in either prophylactic dose regimen or therapeutic dose regimen<br>|
| Critically ill, therapeutic dose regimen<br>Therapeutic anticoagulation for tromboembolic pathology in critically ill patients | Drug: Enoxaparin<br>* Use of enoxaparin in either prophylactic dose regimen or therapeutic dose regimen<br>* Other names: Clexane;Drug: Heparin<br>* Use of heparin in either prophylactic dose regimen or therapeutic dose regimen<br>|
| Covid, prophylactic dose regimen<br>Prophylaxis of deep vein trombosis in Covid patients | Drug: Enoxaparin<br>* Use of enoxaparin in either prophylactic dose regimen or therapeutic dose regimen<br>* Other names: Clexane;Drug: Heparin<br>* Use of heparin in either prophylactic dose regimen or therapeutic dose regimen<br>|
| Covid, therapeutic dose regimen<br>Therapeutic anticoagulation for tromboembolic pathology in Covid patients | Drug: Enoxaparin<br>* Use of enoxaparin in either prophylactic dose regimen or therapeutic dose regimen<br>* Other names: Clexane;Drug: Heparin<br>* Use of heparin in either prophylactic dose regimen or therapeutic dose regimen<br>|

What is the study measuring?
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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 | 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 | Risk factors are minor bleeding, major bleeding | Time of discharge or death | 
| Safety of increased dose of thromboprophylaxis in Covid-19 patients | Special consideration of minor or major bleeding | Time of discharge or death |