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

NCT ID: NCT04829552

Last Updated: 2021-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

704 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-10

Study Completion Date

2020-04-15

Brief Summary

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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

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Conditions

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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William Beaumont Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Faisal Musa, MD

Staff Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beaumont Health System (BHS)

Royal Oak, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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2020-219

Identifier Type: -

Identifier Source: org_study_id

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