AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia
Start Date
10/10/2023
Completion Date
3/31/2029
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).
Detailed 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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Heparin
Conditions
Locations
University of Chicago
Chicago, Illinois 60637
United States
Ochsner Clinic
Jefferson, Louisiana 70121
United States
Maine Medical Centre
Portland, Maine 04102
United States
Henry Ford Health System
Dearborn, Michigan 48128
United States
Cooper University Health Care
Camden, New Jersey 08103
United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Hospital Estadual Dr. Jayme Santos Neves
Serra, Espírito Santo 29166-828
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 do Rocio
Campo Largo, Paraná 83606-177
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 13083-190
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 02189-010
Brazil
HCFMUSP
São Paulo, São Paulo 05403-010
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 T2N 2T9
Canada
Grand Prairie Regional Hospital
Grande Prairie, Alberta T8V 4B1
Canada
Nanaimo Regional General Hospital
Nanaimo, British Columbia
Canada
Vancouver General Hospital
Vancouver, British Columbia V5Z 1M9
Canada
Health Sciences Center Winnipeg
Winnipeg, Manitoba R3A 1R9
Canada
Grace General Hospital
Winnipeg, Manitoba
Canada
St. Boniface General Hospital
Winnipeg, Manitoba
Canada
Memorial University
St. John's, Newfoundland and Labrador A1C 5S7
Canada
Health Sciences North Research Institute
Greater Sudbury, Ontario P3E 2H3
Canada
Hamilton Health Sciences - Juravinski
Hamilton, Ontario
Canada
Hamilton Health Sciences
Hamilton, Ontario
Canada
Markham Stouffville Hospital
Markham, Ontario L3P 7P3
Canada
Hôpital Montfort
Ottawa, Ontario
Canada
The Ottawa Hospital
Ottawa, Ontario
Canada
Niagara Health System - St Catharines Site
Saint Catherines, Ontario L2S 0A9
Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
Canada
University Health Network
Toronto, Ontario M5G2C4
Canada
Centre Hospitalier de Quebec - Hotel-Dieu de Levis
Lévis, Quebec G6V 3Z1
Canada
McGill University Health Centre
Montreal, Quebec H4A3J1
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 S4P 0W5
Canada