Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19.
ATTACC Investigators, ACTIV-4a Investigators, REMAP-CAP Investigators...
https://pubmed.ncbi.nlm.nih.gov/34351721Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID05848713
AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia
Led by University of Manitoba · Updated on 2026-04-21
4000
Participants Needed
64
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Manitoba
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of therapeutic-dose heparin compared to usual care pharmacological thromboprophylaxis in patients hospitalized with community-acquired pneumonia (CAP). This international, open-label, randomized controlled trial aims to understand if higher doses of heparin can improve outcomes by addressing inflammatory and thrombotic processes that contribute to respiratory, cardiac, and organ complications in CAP. The study builds on findings from COVID-19 patients, where therapeutic-dose heparin showed benefits in non-critically ill patients. Participants are randomly assigned to one of two groups. One group receives a daily therapeutic dose of low molecular-weight heparin (LMWH) or unfractionated heparin (UFH) for up to 14 days or until hospital discharge. The other group receives usual care with thromboprophylactic dose anticoagulation following local protocols, with doses not exceeding half the therapeutic level. The investigational arm prefers LMWH but may use UFH, especially in cases of renal compromise, with dosing tailored to patient weight and local standards. During the study, participants will be monitored for survival over 30 days as the primary outcome. Secondary outcomes include bleeding events, heparin-induced thrombocytopenia (HIT), thrombotic events, invasive mechanical ventilation, mortality at multiple time points, hospital-free days, and health-related quality of life. The study involves hospital assessments, close monitoring of safety and clinical status, and tracking of various health measures up to 180 days, ensuring comprehensive evaluation of the treatments under study.
CONDITIONS
Brief Title
AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- Admitted to hospital with suspected or confirmed community-acquired pneumonia
- Radiographic evidence of new or worsening lung infiltrate
- Presence of one or more signs or symptoms of lower respiratory tract infection (new/increased cough or sputum, fever above 37.8°C or below 36°C, abnormal white blood cell count)
- Requires supplemental oxygen for low blood oxygen or increased oxygen if on chronic therapy
- Hospital admission expected to last at least 72 hours from randomization
You will not qualify if you...
- Suspected or confirmed active COVID-19 infection
- Hospital admission longer than 72 hours before randomization
- Receiving non-invasive or invasive ventilation, vasopressors, or extracorporeal life support in ICU at enrollment
- Chronic mechanical ventilation via tracheostomy before hospitalization
- Intended not to use pharmacologic thromboprophylaxis
- Independent indication for therapeutic-dose anticoagulation
- Contraindication to therapeutic-dose anticoagulation including recent significant bleeding, bleeding disorders, cerebral aneurysm or CNS mass, recent ischemic stroke or gastrointestinal bleeding, low platelet count, high INR, or low hemoglobin
- History of heparin-induced thrombocytopenia or heparin allergy
- Recent use of dual anti-platelet inhibitors
- Imminent death anticipated
- Expected transfer to non-study hospital within 72 hours
- Enrollment in other anticoagulation or antiplatelet interventional trials during current hospitalization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 14 days or until hospital discharge
Participants receive therapeutic-dose heparin or usual care thromboprophylactic anticoagulation daily for up to 14 days or until hospital discharge, whichever occurs first.
Daily treatment visits while hospitalized
Follow-up
Duration - Up to 180 days
Participants are monitored for clinical outcomes including survival, bleeding, thrombotic events, mechanical ventilation, mortality, hospital-free days, and quality of life up to 180 days after treatment.
Follow-up visits at 30, 90, and 180 days after treatment
Trial Site Locations
Total: 64 locations
1
University of Chicago
Chicago, Illinois, United States, 60637
Not Yet Recruiting
2
Ochsner Clinic
Jefferson, Louisiana, United States, 70121
Actively Recruiting
3
Maine Medical Centre
Portland, Maine, United States, 04102
Actively Recruiting
4
Henry Ford Health System
Dearborn, Michigan, United States, 48128
Completed
5
Cooper University Health Care
Camden, New Jersey, United States, 08103
Actively Recruiting
6
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
7
Hospital Estadual Dr. Jayme Santos Neves
Serra, Espírito Santo, Brazil, 29166-828
Actively Recruiting
8
Hospital Evangelico de Vila Velha
Vila Velha, Espírito Santo, Brazil
Actively Recruiting
9
Hospital Universitário Cassiano Antonio Moraes
Vitória, Espírito Santo, Brazil
Not Yet Recruiting
10
Santa Casa de Misericordia de Itabuna
Itabuna, Estado de Bahia, Brazil
Completed
11
Hospital Brasilia
Brasília, Federal District, Brazil
Completed
12
Hospital Sao Brasilia
Brasília, Federal District, Brazil
Not Yet Recruiting
13
Instituto de Cardiologia e Transplantes do Distrito Federal
Brasília, Federal District, Brazil
Actively Recruiting
14
Hospital de Messejana Dr. Carlos Alberto Studart Gomes
Goiânia, Goiás, Brazil
Actively Recruiting
15
Hospital Ruy Azeredo
Goiânia, Goiás, Brazil
Actively Recruiting
16
Instituto Goiano de Oncologia e Hematologia - INGOH
Goiânia, Goiás, Brazil
Actively Recruiting
17
Hospital Felicio Rocho
Belo Horizonte, Minas Gerais, Brazil
Actively Recruiting
18
NUPEC-Orizonti
Belo Horizonte, Minas Gerais, Brazil
Completed
19
Hospital do Rocio
Campo Largo, Paraná, Brazil, 83606-177
Actively Recruiting
20
Hospital Santa Cruz
Curitiba, Paraná, Brazil
Actively Recruiting
21
PUCPR
Curitiba, Paraná, Brazil
Completed
22
Hospital Bruno Born
Lajeado, Rio Grande do Sul, Brazil
Actively Recruiting
23
Hospital Sao Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil
Actively Recruiting
24
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Actively Recruiting
25
Hospital Universitario de Santa Maria
Santa Maria, Rio Grande do Sul, Brazil
Actively Recruiting
26
Hospital Sao Jose
Criciúma, Santa Catarina, Brazil
Actively Recruiting
27
Hospital Regional Homero Miranda Gomes
São José, South Carolina, Brazil
Completed
28
Hospital de Reabilitacao de Anomalias Craniofaciais
Bauru, São Paulo, Brazil
Not Yet Recruiting
29
UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu
Botucatu, São Paulo, Brazil
Actively Recruiting
30
Hospital Universitario Sao Francisco na Providencia na Deus
Bragança Paulista, São Paulo, Brazil
Actively Recruiting
31
Fundação Centro Médico de Campinas
Campinas, São Paulo, Brazil, 13083-190
Actively Recruiting
32
IPECC
Campinas, São Paulo, Brazil
Actively Recruiting
33
CiTen - Centro Hospital Municipal Antonio Giglio
Osasco, São Paulo, Brazil
Actively Recruiting
34
Hospital Regional de Presidente Prudente
Presidente Prudente, São Paulo, Brazil
Actively Recruiting
35
Hospital Estadual de Serrana
Ribeirão Preto, São Paulo, Brazil
Not Yet Recruiting
36
Hospital Nipo-Brasileiro
São Paulo, São Paulo, Brazil, 02189-010
Actively Recruiting
37
HCFMUSP
São Paulo, São Paulo, Brazil, 05403-010
Actively Recruiting
38
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Not Yet Recruiting
39
Santa Casa de Misericordia de Sao Paulo
São Paulo, São Paulo, Brazil
Actively Recruiting
40
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Actively Recruiting
41
Grand Prairie Regional Hospital
Grande Prairie, Alberta, Canada, T8V 4B1
Not Yet Recruiting
42
Nanaimo Regional General Hospital
Nanaimo, British Columbia, Canada
Actively Recruiting
43
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
44
Health Sciences Center Winnipeg
Winnipeg, Manitoba, Canada, R3A 1R9
Actively Recruiting
45
Grace General Hospital
Winnipeg, Manitoba, Canada
Actively Recruiting
46
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Actively Recruiting
47
Memorial University
St. John's, Newfoundland and Labrador, Canada, A1C 5S7
Actively Recruiting
48
Health Sciences North Research Institute
Greater Sudbury, Ontario, Canada, P3E 2H3
Actively Recruiting
49
Hamilton Health Sciences - Juravinski
Hamilton, Ontario, Canada
Actively Recruiting
50
Hamilton Health Sciences
Hamilton, Ontario, Canada
Actively Recruiting
51
Markham Stouffville Hospital
Markham, Ontario, Canada, L3P 7P3
Actively Recruiting
52
Hôpital Montfort
Ottawa, Ontario, Canada
Actively Recruiting
53
The Ottawa Hospital
Ottawa, Ontario, Canada
Actively Recruiting
54
Niagara Health System - St Catharines Site
Saint Catherines, Ontario, Canada, L2S 0A9
Actively Recruiting
55
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
56
University Health Network
Toronto, Ontario, Canada, M5G2C4
Not Yet Recruiting
57
Centre Hospitalier de Quebec - Hotel-Dieu de Levis
Lévis, Quebec, Canada, G6V 3Z1
Not Yet Recruiting
58
McGill University Health Centre
Montreal, Quebec, Canada, H4A3J1
Actively Recruiting
59
Centre Hospitalier de l'université de Montréal (CHUM)
Montreal, Quebec, Canada
Actively Recruiting
60
Jewish General Hospital
Montreal, Quebec, Canada
Actively Recruiting
61
CHU de Quebec-University Laval
Québec, Quebec, Canada
Actively Recruiting
62
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Québec, Quebec, Canada
Actively Recruiting
63
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Actively Recruiting
64
Regina General Hospital
Regina, Saskatchewan, Canada, S4P 0W5
Actively Recruiting
Loading map...
Research Team
C
Chantale Pineau
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here