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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Chicago
  Chicago, Illinois, United States Recruiting
• Ochsner Clinic
  Jefferson, Louisiana, United States Recruiting
• Maine Medical Centre
  Portland, Maine, United States Recruiting
• Cooper University Health Care
  Camden, New Jersey, United States Recruiting
• Medical College of Wisconsin
  Milwaukee, Wisconsin, United States Recruiting
• Hospital Estadual Dr. Jayme Santos Neves
  Serra, Espírito Santo, Brazil Recruiting

+18 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Ryan Zarychanski, MD — University of Manitoba
• Study coordinator: Chantale Pineau
• Email: attacc.cap@umanitoba.ca
• Phone: 2042353223

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.