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AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia

Community-acquired Pneumonia

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).

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Conditions de participation

  • Sexe:

    ALL
  • Âges admissibles:

    18 and up

Critères de participation

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

Lieu de l'étude

Grand Prairie Regional Hospital
Grand Prairie Regional Hospital
Grande Prairie, Alberta
Canada

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Primary Contact

Tafi Madzimure, MD

Vancouver General Hospital
Vancouver General Hospital
Vancouver, British Columbia
Canada

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Primary Contact

Ted Steiner, MD

Memorial University
Memorial University
Saint John's, Newfoundland and Labrador
Canada

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Primary Contact

Peter Daley, MD

Hôpital Montfort
Hôpital Montfort
Ottawa, Ontario
Canada

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Primary Contact

Marc Carrier, MD

Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Toronto, Ontario
Canada

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Primary Contact

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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Primary Contact

Emmanuelle Duceppe, MD

Centre Hospitalier Universitaire de Sherbrooke
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec
Canada

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Primary Contact

Francois Lamontagne, MD

Foothills Medical Centre
Foothills Medical Centre
Calgary, Alberta
Canada

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Primary Contact

Deepa Suryanarayan, MD

[email protected]
4039448167
Penticton Regional Hospital
Penticton Regional Hospital
Penticton, British Columbia
Canada

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Primary Contact

Tiffany Bursey, MD

St. Boniface General Hospital
St. Boniface General Hospital
Winnipeg, Manitoba
Canada

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Primary Contact

Vi Dao, MD

Markham Stouffville Hospital
Markham Stouffville Hospital
Markham, Ontario
Canada

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Primary Contact

Paul Lee, MD

Health Sciences North Research Institute
Health Sciences North Research Institute
Sudbury, Ontario
Canada

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Primary Contact

Pandma Puranam, MD

McGill University Health Centre
McGill University Health Centre
Montréal, Quebec
Canada

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Primary Contact

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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Primary Contact

Francois Lallouche, MD

East Kootenay Regional Hospital
East Kootenay Regional Hospital
Cranbrook, British Columbia
Canada

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Primary Contact

Denise Jaworsky, MD

Health Sciences Center Winnipeg
Health Sciences Center Winnipeg
Winnipeg, Manitoba
Canada

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Primary Contact

Brett Houstin, MD

Hamilton Health Sciences - Juravinski
Hamilton Health Sciences - Juravinski
Hamilton, Ontario
Canada

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Primary Contact

Bram Rochwerg, MD

The Ottawa Hospital
The Ottawa Hospital
Ottawa, Ontario
Canada

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Primary Contact

Lana Castellucci, MD

University Health Network
University Health Network
Toronto, Ontario
Canada

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Primary Contact

Jameel Abdulrehman, MD

Jewish General Hospital
Jewish General Hospital
Montréal, Quebec
Canada

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Backup Contact

Vicky Tagalakis, MD

Primary Contact

Susan Khan, MD

Regina General Hospital
Regina General Hospital
Regina, Saskatchewan
Canada

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Primary Contact

Payam Dehghani, MD

Nanaimo Regional General Hospital
Nanaimo Regional General Hospital
Nanaimo, British Columbia
Canada

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Primary Contact

Alistair Teale, MD

Grace General Hospital
Grace General Hospital
Winnipeg, Manitoba
Canada

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Primary Contact

Sylvain Lother, MD

[email protected]
Hamilton Health Sciences
Hamilton Health Sciences
Hamilton, Ontario
Canada

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Primary Contact

Alison Fox-Robichaud, MD

Niagara Health System - St Catharines Site
Niagara Health System - St Catharines Site
St. Catherines, Ontario
Canada

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Primary Contact

Aidan Findlater, MD

[email protected]
Centre Hospitalier de Quebec - Hotel-Dieu de Levis
Centre Hospitalier de Quebec - Hotel-Dieu de Levis
Lévis, Quebec
Canada

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Primary Contact

Patrick Archambault, MD

CHU de Quebec-University Laval
CHU de Quebec-University Laval
Québec, Quebec
Canada

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Primary Contact

Alexis Turgeon, MD, MSc

Étude parrainée par
University of Manitoba
Participants recherchés
Plus d'informations
ID de l'étude: NCT05848713