RECRUITING Phase 3 ClinicalTrials.gov

AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia

Sponsor: University of Manitoba • ClinicalTrials.gov ID: NCT05848713

Registry updated: 2026-09-30

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Description

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).

Interventions

Heparin (Drug)
Preference is for LMWH given ease of administration and possibility of a more favorable safety profile, if no contraindication is present. Enoxaparin, dalteparin, or tinzaparin are acceptable LMWHs to be used for patients in the investigational arm and dose should be based on measured or estimated weight of the patient. Alternatively, intravenous UFH may be used and may be preferred in the presence of significant renal compromise. Intravenous UFH is typically dosed according to total body weight and pragmatically adjusted according to local institutional policy to achieve an activated partial thromboplastin time (aPTT) of 1.5-2.5x the reference value, or a corresponding UFH anti-Xa level. If UFH is used, the availability of a local site policy that specifies an aPTT target in this range or a corresponding anti-Xa value is a requirement.

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

Conditions

Community-acquired Pneumonia

Locations

University of Chicago — Chicago, Illinois, United States
Ochsner Clinic — Jefferson, Louisiana, United States
Maine Medical Centre — Portland, Maine, United States
Henry Ford Health System — Dearborn, Michigan, United States
Cooper University Health Care — Camden, New Jersey, United States
Medical College of Wisconsin — Milwaukee, Wisconsin, United States
Hospital Estadual Dr. Jayme Santos Neves — Serra, Espírito Santo, Brazil
Hospital Evangelico de Vila Velha — Vila Velha, Espírito Santo, Brazil
Santa Casa de Misericordia de Itabuna — Itabuna, Estado de Bahia, Brazil
Hospital Brasilia — Brasília, Federal District, Brazil
Instituto de Cardiologia e Transplantes do Distrito Federal — Brasília, Federal District, Brazil
Hospital de Messejana Dr. Carlos Alberto Studart Gomes — Goiânia, Goiás, Brazil
Hospital Ruy Azeredo — Goiânia, Goiás, Brazil
Instituto Goiano de Oncologia e Hematologia - INGOH — Goiânia, Goiás, Brazil
Hospital São Julião — Campo Grande, Mato Grosso do Sul, Brazil
Santa Casa de Campo Grande — Campo Grande, Mato Grosso do Sul, Brazil
Hospital Felicio Rocho — Belo Horizonte, Minas Gerais, Brazil
NUPEC-Orizonti — Belo Horizonte, Minas Gerais, Brazil
Santa Casa de Misericórdia de Belo Horizonte — Belo Horizonte, Minas Gerais, Brazil
Hospital das Clínicas da Universidade Federal do Triângulo Mineiro — Uberaba, Minas Gerais, Brazil
Hospital do Rocio — Campo Largo, Paraná, Brazil
Hospital Santa Cruz — Curitiba, Paraná, Brazil
PUCPR — Curitiba, Paraná, Brazil
Hospital Clementino Fraga Filho - UFRJ — Rio de Janeiro, Rio de Janeiro, Brazil
Hospital Bruno Born — Lajeado, Rio Grande do Sul, Brazil
Hospital Sao Vicente de Paulo — Passo Fundo, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil
Hospital Universitario de Santa Maria — Santa Maria, Rio Grande do Sul, Brazil
Hospital Sao Jose — Criciúma, Santa Catarina, Brazil
Hospital Regional Homero Miranda Gomes — São José, South Carolina, Brazil
UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu — Botucatu, São Paulo, Brazil
Hospital Universitario Sao Francisco na Providencia na Deus — Bragança Paulista, São Paulo, Brazil
Fundação Centro Médico de Campinas — Campinas, São Paulo, Brazil
IPECC — Campinas, São Paulo, Brazil
CiTen - Centro Hospital Municipal Antonio Giglio — Osasco, São Paulo, Brazil
Hospital Regional de Presidente Prudente — Presidente Prudente, São Paulo, Brazil
Hospital Estadual de Serrana — Ribeirão Preto, São Paulo, Brazil
Hospital Nipo-Brasileiro — São Paulo, São Paulo, Brazil
HCFMUSP — São Paulo, São Paulo, Brazil
Santa Casa de Misericordia de Sao Paulo — São Paulo, São Paulo, Brazil
Foothills Medical Centre - Alberta Health Services — Calgary, Alberta, Canada
Grand Prairie Regional Hospital — Grande Prairie, Alberta, Canada
Nanaimo Regional General Hospital — Nanaimo, British Columbia, Canada
Penticton Regional Hospital — Penticton, British Columbia, Canada
Vancouver General Hospital — Vancouver, British Columbia, Canada
Health Sciences Center Winnipeg — Winnipeg, Manitoba, Canada
Grace General Hospital — Winnipeg, Manitoba, Canada
St. Boniface General Hospital — Winnipeg, Manitoba, Canada
Memorial University — St. John's, Newfoundland and Labrador, Canada
Health Sciences North Research Institute — Greater Sudbury, Ontario, Canada
Health Sciences North ResearchInstitute (HSNRI) — Greater Sudbury, Ontario, Canada
Hamilton Health Sciences - Juravinski — Hamilton, Ontario, Canada
Hamilton Health Sciences — Hamilton, Ontario, Canada
Markham Stouffville Hospital — Markham, Ontario, Canada
Hôpital Montfort — Ottawa, Ontario, Canada
The Ottawa Hospital — Ottawa, Ontario, Canada
Niagara Health System - St Catharines Site — Saint Catherines, Ontario, Canada
Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
St. Michael's Hospital — Toronto, Ontario, Canada
McGill University Health Centre — Montreal, Quebec, Canada
Centre Hospitalier de l'université de Montréal (CHUM) — Montreal, Quebec, Canada
Jewish General Hospital — Montreal, Quebec, Canada
CHU de Quebec-University Laval — Québec, Quebec, Canada
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ) — Québec, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke — Sherbrooke, Quebec, Canada
Regina General Hospital — Regina, Saskatchewan, Canada
University of Saskatchewan — Saskatoon, Saskatchewan, Canada
Hospital General Regional 1. Carlos MacGregor Sánchez Navarro — Mexico City, Mexico City, Mexico

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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