Prophylactic Versus Therapeutic Dose Anticoagulation In COVID-19 Infection at the Time of Admission To Critical Care Units
Completed
- Conditions
 - Covid19
 
- Registration Number
 - NCT04829552
 
- Lead Sponsor
 - William Beaumont Hospitals
 
- Brief Summary
 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.
- Detailed Description
 Not available
Recruitment & Eligibility
- Status
 - COMPLETED
 
- Sex
 - All
 
- Target Recruitment
 - 704
 
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.
 
Study & Design
- Study Type
 - OBSERVATIONAL
 
- Study Design
 - Not specified
 
- Primary Outcome Measures
 Name Time Method Inpatient all-cause mortality During hospitalization, up to 6 months 
- Secondary Outcome Measures
 Name Time Method Rates of major bleeding events During hospitalization, up to 6 months as defined by the International Society on Thrombosis and Hemostasis
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 
Trial Locations
- Locations (1)
 Beaumont Health System (BHS)
🇺🇸Royal Oak, Michigan, United States
Beaumont Health System (BHS)🇺🇸Royal Oak, Michigan, United States
