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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04829552

Enrollment

704

Registered

2021-04-02

Start date

2020-03-10

Completion date

2020-04-15

Last updated

2021-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

anticoagulation, COVID19, thrombosis, heparin, coagulopathy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Inpatient all-cause mortality	During hospitalization, up to 6 months

Secondary

Measure	Time frame	Description
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	—

Countries

United States

Outcome results