AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia

Recruiting now · Phase 3

Conditions studied: Community-acquired Pneumonia

In brief

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).

Key facts

Study ID

NCT05848713

Run by

University of Manitoba

People needed

4000

Starts

2023-10-10

Expected to finish

2029-03-31

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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:
• Non-traumatic bleeding that requires medical evaluation or hospitalization within 30 days prior to CAP hospital admission
• History of an inherited or acquired bleeding disorder
• Cerebral aneurysm or mass lesions of the central nervous system
• Ischemic stroke within 3 months of hospital admission
• Gastrointestinal bleeding within 3 months of hospital admission
• Platelet count <50 x109/L OR INR >2.0 OR hemoglobin <80 g/L at the time of screening
• Other physician-perceived contraindications to therapeutic anticoagulation
• 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

Where it is running

• CiTen - Centro Hospital Municipal Antonio Giglio — Osasco, São Paulo, Brazil (enrolling)
• Hospital Regional de Presidente Prudente — Presidente Prudente, São Paulo, Brazil (enrolling)
• UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu — Botucatu, São Paulo, Brazil (enrolling)
• IPECC — Campinas, São Paulo, Brazil (enrolling)
• Maine Medical Centre — Portland, Maine, United States (enrolling)
• Hospital Estadual Dr. Jayme Santos Neves — Serra, Espírito Santo, Brazil (enrolling)
• Hospital Evangelico de Vila Velha — Vila Velha, Espírito Santo, Brazil (enrolling)
• Hospital Sao Jose — Criciúma, Santa Catarina, Brazil (enrolling)
• Hospital Universitario Sao Francisco na Providencia na Deus — Bragança Paulista, São Paulo, Brazil (enrolling)
• Fundação Centro Médico de Campinas — Campinas, São Paulo, Brazil (enrolling)
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
• Instituto de Cardiologia e Transplantes do Distrito Federal — Brasília, Federal District, Brazil (enrolling)
• Hospital de Messejana Dr. Carlos Alberto Studart Gomes — Goiânia, Goiás, Brazil (enrolling)
• Hospital Ruy Azeredo — Goiânia, Goiás, Brazil (enrolling)
• Instituto Goiano de Oncologia e Hematologia - INGOH — Goiânia, Goiás, Brazil (enrolling)
• Hospital Felicio Rocho — Belo Horizonte, Minas Gerais, Brazil (enrolling)
• Ochsner Clinic — Jefferson, Louisiana, United States (enrolling)
• Hospital do Rocio — Campo Largo, Paraná, Brazil (enrolling)
• Hospital Santa Cruz — Curitiba, Paraná, Brazil (enrolling)
• Cooper University Health Care — Camden, New Jersey, United States (enrolling)
• Hospital Bruno Born — Lajeado, Rio Grande do Sul, Brazil (enrolling)
• Hospital Sao Vicente de Paulo — Passo Fundo, Rio Grande do Sul, Brazil (enrolling)
• Hospital de Clínicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
• Hospital Universitario de Santa Maria — Santa Maria, Rio Grande do Sul, Brazil (enrolling)
• Hospital Nipo-Brasileiro — São Paulo, São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

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