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

Study Timeline

• Study Start: 2020-03-10
• Primary Completion: 2020-04-15
• Study Completion: 2020-04-15
• Status Verified: 2021-03
• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-04-01
• Last Update Submitted: 2021-04-01
• Study First Posted: 2021-04-02
• Last Update Posted: 2021-04-02

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