Recruiting
Phase 3

AntiThrombotic Therapy

Sponsor:

University of Manitoba

Code:

NCT05848713

Conditions

Community-acquired Pneumonia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Heparin

Study Details

Brief summary:

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 ID

NCT05848713

Start date

Oct 10, 2023

Status verified date

Apr, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

4000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Therapeutic-Dose Heparin

Participants randomized to the investigational arm will receive a pragmatic strategy of therapeutic-dose low molecular-weight heparin (LMWH) or unfractionated heparin (UFH) administered daily for up to 14 days or until hospital discharge, whichever occurs first. Participants should start receiving study drug as soon as possible following randomization.

no intervention: Usual Care

Participants randomized to the control arm will receive usual care thromboprophylactic dose anticoagulation according to local practice. To ensure adequate separation between the study groups, the dose of heparin/LMWH used in the usual care arm should not equal more than half of the approved therapeutic dose for that agent according to local VTE treatment protocols.

Interventions

Heparin

Preference is for LMWH given ease of administration and possibility of a more favorable safety profile, if no contraindication is present. Enoxaparin, dalteparin, or tinzaparin are acceptable LMWHs to be used for patients in the investigational arm and dose should be based on measured or estimated weight of the patient.

Alternatively, intravenous UFH may be used and may be preferred in the presence of significant renal compromise. Intravenous UFH is typically dosed according to total body weight and pragmatically adjusted according to local institutional policy to achieve an activated partial thromboplastin time (aPTT) of 1.5-2.5x the reference value, or a corresponding UFH anti-Xa level. If UFH is used, the availability of a local site policy that specifies an aPTT target in this range or a corresponding anti-Xa value is a requirement.

Primary outcome measure

  • Ordinal endpoint reflecting survival [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Locations

Ochsner Clinic

Recruiting

Jefferson, Louisiana, United States, 70121

Maine Medical Centre

Recruiting

Portland, Maine, United States, 04102

Principal Investigator:

Daniel Meyer, MD

Cooper University Health Care

Recruiting

Camden, New Jersey, United States, 08103

Principal Investigator:

Adam Green, MD

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Principal Investigator:

Alisha Sharma, MD

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Deepa Suryanarayan, MD

4039448167dsuryana@ucalgary.ca

Principal Investigator:

Deepa Suryanarayan, MD

Nanaimo Regional General Hospital

Recruiting

Nanaimo, British Columbia, Canada

Principal Investigator:

Alistair Teale, MD

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Principal Investigator:

Ted Steiner, MD

Health Sciences Center Winnipeg

Recruiting

Winnipeg, Manitoba, Canada, R3A 1R9

Grace General Hospital

Recruiting

Winnipeg, Manitoba, Canada

Contacts

Sylvain Lother, MD

sylvain.lother@umanitoba.ca

Principal Investigator:

Sylvain Lother, MD

St. Boniface General Hospital

Recruiting

Winnipeg, Manitoba, Canada

Principal Investigator:

Terry Wuerz, MD

Memorial University

Recruiting

St. John's, Newfoundland and Labrador, Canada, A1C 5S7

Principal Investigator:

Peter Daley, MD

Health Sciences North Research Institute

Recruiting

Greater Sudbury, Ontario, Canada, P3E 2H3

Principal Investigator:

Pandma Puranam, MD

Hamilton Health Sciences - Juravinski

Recruiting

Hamilton, Ontario, Canada

Principal Investigator:

Bram Rochwerg, MD

Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada

Principal Investigator:

Alison Fox-Robichaud, MD

Markham Stouffville Hospital

Recruiting

Markham, Ontario, Canada, L3P 7P3

Principal Investigator:

Paul Lee, MD

Hôpital Montfort

Recruiting

Ottawa, Ontario, Canada

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada

Niagara Health System - St Catharines Site

Recruiting

Saint Catherines, Ontario, Canada, L2S 0A9

Contacts

Principal Investigator:

Aidan Findlater, MD

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Principal Investigator:

Jonathan Zipursky, MD

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A3J1

Centre Hospitalier de l'université de Montréal (CHUM)

Recruiting

Montreal, Quebec, Canada

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada

CHU de Quebec-University Laval

Recruiting

Québec, Quebec, Canada

Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)

Recruiting

Québec, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada

Principal Investigator:

Francois Lamontagne, MD

Regina General Hospital

Recruiting

Regina, Saskatchewan, Canada, S4P 0W5

Principal Investigator:

Payam Dehghani, MD

More Information

Sponsor

University of Manitoba

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

  • Pneumonia
  • Heparin
  • Anticoagulation
  • Community acquired pneumonia
  • Unfractionated Heparin
  • Low Molecular Weight Heparin
  • Dalteparin
  • Enoxaparin
  • Tinzaparin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Manitoba on 2026-04-21.