Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
Control group: low dose group. 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. 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.

Recruiting Locations

More Details

NCT ID
NCT04829552
Status
Completed
Sponsor
William Beaumont Hospitals

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.