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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04829552
• Other study ID #: 2020-219
• Status: Completed
• Start date: March 10, 2020
• Est. completion date: April 15, 2020

Study information

• Verified date: March 2021
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 704
• Est. completion date: April 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Infection

Locations

Country	Name	City	State
United States	Beaumont Health System (BHS)	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inpatient all-cause mortality		During hospitalization, up to 6 months
Secondary	Rates of major bleeding events	as defined by the International Society on Thrombosis and Hemostasis	During hospitalization, up to 6 months
Secondary	Rates of venous thromboses		During hospitalization, up to 6 months
Secondary	Intensive care unit/Step down unit length of stay		During hospitalization, up to 6 months