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Using heparin to improve outcomes in patients with community-acquired pneumonia

AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia

Phase 3 Interventional University of Manitoba · NCT05848713

This study is testing whether giving heparin to patients with community-acquired pneumonia can help them avoid complications and recover better than standard care.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment4000 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity of Manitoba Academic / other
Locations64 sites (Chicago, Illinois and 63 other locations)
Trial IDNCT05848713 on ClinicalTrials.gov

What this trial studies

This international, open-label, stratified randomized controlled trial aims to compare the effects of therapeutic-dose heparin against usual care pharmacological thromboprophylaxis in patients hospitalized with community-acquired pneumonia (CAP). The study will evaluate the impact of heparin on thrombotic complications and overall clinical outcomes in this patient population. By employing Bayesian adaptive stopping rules, the trial seeks to determine the efficacy of heparin in reducing morbidity and mortality associated with CAP. The research is motivated by the need to address the inflammatory and thrombotic processes that contribute to poor outcomes in hospitalized patients with pneumonia.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are hospitalized with suspected or confirmed community-acquired pneumonia requiring supplemental oxygen.

Not a fit: Patients with suspected or confirmed active COVID-19 infection or those requiring intensive care support are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce complications and mortality in patients hospitalized with community-acquired pneumonia.

How similar studies have performed: Previous studies have shown that therapeutic-dose anticoagulation can improve outcomes in COVID-19 patients, suggesting potential benefits for similar approaches in non-COVID-19 pneumonia, though this specific application is novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Chicago, Illinois and 63 other locations

+14 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Community-acquired PneumoniaPneumoniaHeparinAnticoagulationCommunity acquired pneumoniaUnfractionated HeparinLow Molecular Weight HeparinDalteparin
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.