Hospital Felicio Rocho | Health Sciences Center
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About
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).
Full description
The global incidence of hospitalization due to CAP is high and associated with substantive morbidity and mortality. Thrombotic complications - including venous, arterial, and possibly microvascular - occur commonly in hospitalized patients across many etiologies of CAP. Poor outcomes may be mediated by both inflammatory and thrombotic processes leading to respiratory, cardiac, and other end organ dysfunction. There are currently no established therapies that modify the potentially maladaptive immunothrombosis pathway in CAP.
Therapeutic-dose anticoagulation with heparin reduces disease progression and mortality in non-critically ill patients hospitalized with COVID-19 with an acceptable safety profile. COVID-19 shares pathogenic features, including activation of the inflammatory and coagulation cascades, with other pneumonias. Whether therapeutic-dose heparin confers similar clinical benefits in non-COVID-19 CAP is unknown.
Enrollment
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Inclusion criteria
Patients ≥18 years of age
Admitted to hospital for a suspected or confirmed diagnosis of CAP defined by:
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
Requires supplemental oxygen to treat hypoxemia (or requires an increased level of supplemental oxygen if on chronic oxygen therapy)
Hospital admission anticipated to last ≥72 hours from randomization
Exclusion criteria
Suspected or confirmed active COVID-19 infection
Hospital admission for >72 hours prior to randomization
Patients receiving non-invasive or invasive ventilation, vasopressors, or extracorporeal life support (ECLS) within an ICU at the time of enrollment
Requirement for chronic mechanical ventilation via tracheostomy prior to hospitalization
Patients for whom the intent is to not use pharmacologic thromboprophylaxis
Patients with an independent indication for therapeutic-dose anticoagulation
Patients with a contraindication to therapeutic-dose anticoagulation, including:
History of heparin induced thrombocytopenia (HIT) or other heparin allergy
Current or recent (within 7 days of screening) use of dual anti-platelet inhibitors (For example; Aspirin + one of the following; clopidogrel, ticagrelor, prasugrel)
Patients in whom imminent death is anticipated
Anticipated transfer to another hospital that is not a study site within 72 hours of randomization
Enrollment in other interventional trials related to anticoagulation or antiplatelet therapy during current hospitalization
Primary purpose
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4,000 participants in 2 patient groups
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Central trial contact
Chantale Pineau
Data sourced from clinicaltrials.gov
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