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RECRUITING

NCT05848713

PHASE3

AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia

Sponsor: University of Manitoba

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

4000

Start Date

2023-10-10

Completion Date

2029-03-31

Last Updated

2026-02-03

Healthy Volunteers

Conditions

Community-acquired Pneumonia

Interventions

DRUG

Heparin

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.

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

Locations (62)

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

Hospital Universitário Cassiano Antonio Moraes

Vitória, Espírito Santo, Brazil

Santa Casa de Misericordia de Itabuna

Itabuna, Estado de Bahia, Brazil

Hospital Brasilia

Brasília, Federal District, Brazil

Hospital Sao 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 Felicio Rocho

Belo Horizonte, Minas Gerais, Brazil

NUPEC-Orizonti

Belo Horizonte, Minas Gerais, Brazil

Hospital Santa Cruz

Curitiba, Paraná, Brazil

PUCPR

Curitiba, Paraná, 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

Hospital de Reabilitacao de Anomalias Craniofaciais

Bauru, São Paulo, 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

HCFMUSP

São Paulo, São Paulo, Brazil

Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Santa Casa de Misericordia de Sao Paulo

São Paulo, São Paulo, Brazil

Foothills Medical Centre

Calgary, Alberta, Canada

Grand Prairie Regional Hospital

Grande Prairie, Alberta, Canada

Nanaimo Regional General Hospital

Nanaimo, 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

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

University Health Network

Toronto, Ontario, Canada

Centre Hospitalier de Quebec - Hotel-Dieu de Levis

Lévis, Quebec, 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

Clinical Research Directory

AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (62)