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

NCT04829552 | Completed

• 1 other identifier: 2020-219
• Study Type: observational
• Target: 704
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

anticoagulation; COVID19; thrombosis; heparin; coagulopathy

Outcome Measures

Primary Outcomes (1)

• Inpatient all-cause mortality

  During hospitalization, up to 6 months

Secondary Outcomes (3)

• Rates of major bleeding events

  During hospitalization, up to 6 months

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who were admitted to Beaumont Health System (Michigan, USA) ICU/SDU in the period of March 10th to April 15th, 2020.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Beaumont Health System (BHS)

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

COVID-19; Thrombosis; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: April 2, 2021
• Study Start: March 10, 2020
• Primary Completion: April 15, 2020
• Study Completion: April 15, 2020
• Last Updated: April 2, 2021

Record last verified: 2021-03

Locations

US (1)