AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia

Description

This is an international, open-label, stratified randomized controlled trial with Bayesian adaptive stopping rules to compare the effects of therapeutic-dose heparin vs. usual care pharmacological thromboprophylaxis on outcomes in patients admitted to hospital with community acquired pneumonia (CAP).

Conditions

Community-acquired Pneumonia

Study Overview

Study Details

Study overview

This is an international, open-label, stratified randomized controlled trial with Bayesian adaptive stopping rules to compare the effects of therapeutic-dose heparin vs. usual care pharmacological thromboprophylaxis on outcomes in patients admitted to hospital with community acquired pneumonia (CAP).

AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia

AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia

Condition
Community-acquired Pneumonia
Intervention / Treatment

-

Contacts and Locations

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Jefferson

Ochsner Clinic, Jefferson, Louisiana, United States, 70121

Portland

Maine Medical Centre, Portland, Maine, United States, 04102

Dearborn

Henry Ford University, Dearborn, Michigan, United States, 48128

Camden

Cooper University Health Care, Camden, New Jersey, United States, 08103

Milwaukee

Medical College of Wisconsin, Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Patients ≥18 years of age
  • 2. Admitted to hospital for a suspected or confirmed diagnosis of CAP defined by:
  • 1. Radiographic evidence of new or worsening infiltrate
  • 2. One or more of the following signs and/or symptoms of lower respiratory tract infection
  • 3. Requires supplemental oxygen to treat hypoxemia (or requires an increased level of supplemental oxygen if on chronic oxygen therapy)
  • 4. Hospital admission anticipated to last ≥72 hours from randomization
  • 1. Suspected or confirmed active COVID-19 infection
  • 2. Hospital admission for \>72 hours prior to randomization
  • 3. Patients receiving non-invasive or invasive ventilation, vasopressors, or extracorporeal life support (ECLS) within an ICU at the time of enrollment
  • 4. Requirement for chronic mechanical ventilation via tracheostomy prior to hospitalization
  • 5. Patients for whom the intent is to not use pharmacologic thromboprophylaxis
  • 6. Patients with an independent indication for therapeutic-dose anticoagulation
  • 7. Patients with a contraindication to therapeutic-dose anticoagulation, including:
  • 1. Non-traumatic bleeding that requires medical evaluation or hospitalization within 30 days prior to CAP hospital admission
  • 2. History of an inherited or acquired bleeding disorder
  • 3. Cerebral aneurysm or mass lesions of the central nervous system
  • 4. Ischemic stroke within 3 months of hospital admission
  • 5. Gastrointestinal bleeding within 3 months of hospital admission
  • 6. Platelet count \<50 x109/L OR INR \>2.0 OR hemoglobin \<80 g/L at the time of screening
  • 7. Other physician-perceived contraindications to therapeutic anticoagulation
  • 8. History of heparin induced thrombocytopenia (HIT) or other heparin allergy
  • 9. Current or recent (within 7 days of screening) use of dual anti-platelet inhibitors (For example; Aspirin + one of the following; clopidogrel, ticagrelor, prasugrel)
  • 10. Patients in whom imminent death is anticipated
  • 11. Anticipated transfer to another hospital that is not a study site within 72 hours of randomization
  • 12. Enrollment in other interventional trials related to anticoagulation or antiplatelet therapy during current hospitalization

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Manitoba,

Ryan Zarychanski, MD, PRINCIPAL_INVESTIGATOR, University of Manitoba

Patrick Lawler, MD, PRINCIPAL_INVESTIGATOR, University Health Network and McGill University

Sylvain Lother, MD, PRINCIPAL_INVESTIGATOR, University of Manitoba

Alexis Turgeon, MD, PRINCIPAL_INVESTIGATOR, L'Universite Laval

Study Record Dates

2029-03-31