Heparin for Community-Acquired Pneumonia
(ATTACC-CAP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether heparin, an anticoagulant used to prevent and treat blood clots, can improve outcomes for patients hospitalized with community-acquired pneumonia. Researchers compare therapeutic doses of heparin to the usual dose given to prevent blood clots. The trial targets patients admitted to the hospital with pneumonia who need extra oxygen. Participants should not have COVID-19 or other serious conditions requiring intensive care. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are currently using dual anti-platelet inhibitors, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that heparin is generally safe for humans. Although specific safety data for its use in treating community-acquired pneumonia is lacking, extensive knowledge about its safety comes from other applications. Heparin has been widely used in various medical situations, enhancing understanding of its safety profile.
Past studies have tested heparin at treatment doses in patients with other illnesses, such as COVID-19, who were not critically ill. These studies suggest it can improve patient outcomes without major safety issues. However, all medications can have side effects, which should be considered when deciding to join a trial.
Prospective participants might find reassurance in knowing that heparin is already a well-tolerated treatment for other conditions.12345Why do researchers think this study treatment might be promising for pneumonia?
Researchers are excited about using therapeutic-dose heparin for community-acquired pneumonia because it offers a new approach to treatment. Unlike standard care, which typically involves lower-dose anticoagulation to prevent blood clots, therapeutic-dose heparin directly targets the blood clotting process more aggressively. This method could potentially reduce inflammation and improve respiratory function more rapidly, as it addresses the underlying coagulation issues that can worsen pneumonia symptoms. By exploring this higher dosing strategy, researchers hope to enhance patient outcomes and speed up recovery times.
What evidence suggests that heparin might be an effective treatment for community-acquired pneumonia?
Research has shown that therapeutic-dose heparin, which participants in this trial may receive, might help people with community-acquired pneumonia. One study found that heparin was associated with more days without the need for organ support, meaning patients either survived without dying in the hospital or required less machine assistance. Another study indicated that heparin could reduce the risk of dying in the hospital, especially for patients with moderate sepsis-induced coagulopathy, a condition where blood clotting is impaired. Heparin may also improve short-term survival for critically ill patients with pneumonia-related sepsis. Overall, these findings suggest that therapeutic-dose heparin could benefit patients with severe pneumonia.12567
Who Is on the Research Team?
Alexis Turgeon, MD
Principal Investigator
L'Universite Laval
Ryan Zarychanski, MD
Principal Investigator
University of Manitoba
Patrick Lawler, MD
Principal Investigator
University Health Network and McGill University
Sylvain Lother, MD
Principal Investigator
University of Manitoba
Are You a Good Fit for This Trial?
Adults hospitalized with community-acquired pneumonia (CAP) needing oxygen, expected to stay at least 72 hours post-randomization. They must have a primary diagnosis of CAP with new or worsening lung infiltrates and symptoms of lower respiratory infection. Excluded are those admitted over 72 hours, on chronic ventilation, not using thromboprophylaxis, needing full anticoagulation for other reasons, suspected COVID-19, in ICU on life support measures at enrollment time, or with bleeding risks.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive therapeutic-dose heparin or usual care thromboprophylaxis for up to 14 days or until hospital discharge
Follow-up
Participants are monitored for survival, bleeding events, and thrombotic events
Extended Follow-up
Participants are monitored for thrombotic events and health-related quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Heparin
Heparin is already approved in European Union, United States, Canada for the following indications:
- Prevention of thromboembolic disorders
- Treatment of deep vein thrombosis
- Treatment of pulmonary embolism
- Prevention of clotting in extracorporeal circuits
- Prevention and treatment of deep vein thrombosis and pulmonary embolism
- Prevention of postoperative deep vein thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery
- Atrial fibrillation with embolization
- Treatment of acute and chronic consumptive coagulopathy
- Prevention of thromboembolic disorders
- Treatment of deep vein thrombosis
- Treatment of pulmonary embolism
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Manitoba
Lead Sponsor
Canadian Critical Care Trials Group
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Ozmosis Research Inc.
Industry Sponsor
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
Collaborator
Research Manitoba
Collaborator
AVANTI
Collaborator