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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Critically ill, prophylactic dose regimen | Prophylaxis of deep vein trombosis in critically ill patients |
| |
| Critically ill, therapeutic dose regimen | Therapeutic anticoagulation for tromboembolic pathology in critically ill patients |
| |
| Covid, prophylactic dose regimen | Prophylaxis of deep vein trombosis in Covid patients |
| |
| Covid, therapeutic dose regimen | Therapeutic anticoagulation for tromboembolic pathology in Covid patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin | Drug | Use of enoxaparin in either prophylactic dose regimen or therapeutic dose regimen |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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COVID-19 patients and other critical ill patients, during their stay in the intensive care unit of the Ghent University Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Harlinde Peperstraete, MD | University Hospital, Ghent | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Ghent | 9000 | Belgium |
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|
| Heparin | Drug | Use of heparin in either prophylactic dose regimen or therapeutic dose regimen |
|
Special consideration of minor or major bleeding
| Time of discharge or death |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D020246 | Venous Thrombosis |
| D020141 | Hemostatic Disorders |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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