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Completed

NCT Number: NCT04829552

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

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.

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Key information

Conditions

Covid19 COVID-19 Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Embolism and Thrombosis Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Thrombosis Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beaumont Health System (BHS)

Royal Oak, Michigan, 48073, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Inpatient all-cause mortality

    Time frame: During hospitalization, up to 6 months

Secondary outcomes

  1. Rates of major bleeding events

    Time frame: During hospitalization, up to 6 months

    as defined by the International Society on Thrombosis and Hemostasis

  2. Rates of venous thromboses

    Time frame: During hospitalization, up to 6 months

  3. Intensive care unit/Step down unit length of stay

    Time frame: During hospitalization, up to 6 months

Sponsors and collaborators

Lead sponsor

Corewell Health East

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 2, 2021
Registry last updated
Apr 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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