Prophylactic Versus Therapeutic Dose Anticoagulation In COVID-19 Infection at the Time of Admission To Critical Care Units

Study Overview
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Brief Summary
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This is a multi-center, retrospective, study to determine if therapeutic dose anticoagulation (High dose group) improves inpatient mortality in severely ill patients with COVID-19 compared to prophylactic dose anticoagulation (Low dose group). The study involved 704 individuals who were admitted to Beaumont Health System (BHS) from March 10th to April 15th, 2020.

Official Title
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Prophylactic Versus Therapeutic Dose Anticoagulation In COVID-19 Infection at the Time of Admission To Critical Care Units: A Multicenter Retrospective Cohort Study in the Beaumont Healthcare System

Conditions
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Covid19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years old positive reverse transcription-polymerase chain reaction (rRT-PCR) test for the qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens. Intensive care unit (ICU) patient or Step-down unit (SDU) patient on invasive mechanical ventilation, BiPAP, 100% non-rebreather mask, or high flow oxygen or supplemental oxygen of at least 4 liters per minute nasal cannula. peak d-dimer levels exceeding 1,000 mcg/mL at any time during admission. Exclusion Criteria: Hospital length of stay less than 5 days. Hemorrhage before ICU/SDU admission. Treatment with an anticoagulant other than low molecular weight heparin or unfractionated heparin. Constant treatment with the same dose of anticoagulant for less than 5 days.

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 |
| --- | --- |
| Control group: low dose group.<br>patients treated with subcutaneous low molecular weight heparin 40 mg once daily or unfractionated heparin 5000 IU twice or three times daily for at least 5 days. | |
| Study group: high dose group.<br>Patients treated with subcutaneous low molecular weight heparin 1 mg/kg twice daily or 1.5 mg/kg daily or a continuous intravenous infusion of unfractionated heparin for at least 5 days. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inpatient all-cause mortality |  | During hospitalization, up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of major bleeding events | as defined by the International Society on Thrombosis and Hemostasis | During hospitalization, up to 6 months | 
| Rates of venous thromboses |  | During hospitalization, up to 6 months | 
| Intensive care unit/Step down unit length of stay |  | During hospitalization, up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anticoagulation, COVID19, thrombosis, heparin, coagulopathy