AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia

Launched by UNIVERSITY OF MANITOBA · Apr 28, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how a specific blood-thinning medication, called therapeutic-dose heparin, affects patients who are hospitalized with community-acquired pneumonia (CAP). The goal is to see if this treatment can help improve health outcomes compared to the usual care methods that prevent blood clots. If you're at least 18 years old and have been admitted to the hospital with symptoms or a confirmed diagnosis of CAP, you might be eligible to participate. This includes having certain signs of infection, needing extra oxygen, and a hospital stay expected to last for at least three days.

If you join the study, you’ll be randomly assigned to receive either the heparin treatment or the standard care. The study is actively recruiting participants, and it’s open to people of all genders. However, some individuals may not qualify, such as those with certain recent health issues or those currently in critical care. Overall, this trial is an important step in understanding how more effective blood-thinning treatments can potentially improve recovery for patients with pneumonia.

Gender

ALL

Eligibility 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