AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia (NCT05848713) | Clinical Trial Compass
RecruitingPhase 3
AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia
United States4,000 participantsStarted 2023-10-10
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients ≥18 years of age
✓. Admitted to hospital for a suspected or confirmed diagnosis of CAP defined by:
✓. Radiographic evidence of new or worsening infiltrate
✓. One or more of the following signs and/or symptoms of lower respiratory tract infection
✓. 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: