AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia
Community-acquired PneumoniaThis 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).
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
Inclusion 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
i. New or increased cough or sputum production ii. Fever of \> 37.8C or temperature \< 36C iii. WBC \> 11 x 109/L or \< 4 x 109/L c. The primary diagnosis is believed to be CAP as per the attending physician
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
Exclusion Criteria:
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
Study Location
Grand Prairie Regional Hospital
Grand Prairie Regional HospitalGrande Prairie, Alberta
Canada
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Tafi Madzimure, MD
Vancouver General Hospital
Vancouver General HospitalVancouver, British Columbia
Canada
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Ted Steiner, MD
Memorial University
Memorial UniversitySaint John's, Newfoundland and Labrador
Canada
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Peter Daley, MD
Hôpital Montfort
Hôpital MontfortOttawa, Ontario
Canada
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Marc Carrier, MD
Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences CentreToronto, Ontario
Canada
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Jonathan Zipursky, MD
Centre Hospitalier de l'université de Montréal (CHUM)
Centre Hospitalier de l'université de Montréal (CHUM)Montréal, Quebec
Canada
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Emmanuelle Duceppe, MD
Centre Hospitalier Universitaire de Sherbrooke
Centre Hospitalier Universitaire de SherbrookeSherbrooke, Quebec
Canada
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Francois Lamontagne, MD
Foothills Medical Centre
Foothills Medical CentreCalgary, Alberta
Canada
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Penticton Regional Hospital
Penticton Regional HospitalPenticton, British Columbia
Canada
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Tiffany Bursey, MD
St. Boniface General Hospital
St. Boniface General HospitalWinnipeg, Manitoba
Canada
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Vi Dao, MD
Markham Stouffville Hospital
Markham Stouffville HospitalMarkham, Ontario
Canada
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Paul Lee, MD
Health Sciences North Research Institute
Health Sciences North Research InstituteSudbury, Ontario
Canada
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Pandma Puranam, MD
McGill University Health Centre
McGill University Health CentreMontréal, Quebec
Canada
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Emily Gibson McDonald, MD, MSc
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)Québec, Quebec
Canada
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Francois Lallouche, MD
East Kootenay Regional Hospital
East Kootenay Regional HospitalCranbrook, British Columbia
Canada
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Denise Jaworsky, MD
Health Sciences Center Winnipeg
Health Sciences Center WinnipegWinnipeg, Manitoba
Canada
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Brett Houstin, MD
Hamilton Health Sciences - Juravinski
Hamilton Health Sciences - JuravinskiHamilton, Ontario
Canada
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Bram Rochwerg, MD
The Ottawa Hospital
The Ottawa HospitalOttawa, Ontario
Canada
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Lana Castellucci, MD
University Health Network
University Health NetworkToronto, Ontario
Canada
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Jameel Abdulrehman, MD
Jewish General Hospital
Jewish General HospitalMontréal, Quebec
Canada
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Vicky Tagalakis, MD
Susan Khan, MD
Regina General Hospital
Regina General HospitalRegina, Saskatchewan
Canada
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Payam Dehghani, MD
Nanaimo Regional General Hospital
Nanaimo Regional General HospitalNanaimo, British Columbia
Canada
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Alistair Teale, MD
Grace General Hospital
Grace General HospitalWinnipeg, Manitoba
Canada
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Hamilton Health Sciences
Hamilton Health SciencesHamilton, Ontario
Canada
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Alison Fox-Robichaud, MD
Niagara Health System - St Catharines Site
Niagara Health System - St Catharines SiteSt. Catherines, Ontario
Canada
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Centre Hospitalier de Quebec - Hotel-Dieu de Levis
Centre Hospitalier de Quebec - Hotel-Dieu de LevisLévis, Quebec
Canada
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Patrick Archambault, MD
CHU de Quebec-University Laval
CHU de Quebec-University LavalQuébec, Quebec
Canada
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Alexis Turgeon, MD, MSc
- Study Sponsored By
- University of Manitoba
- Participants Required
- More Information
- Study ID:
NCT05848713