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Recruiting Not applicable NCT04754022

Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery

No applicable phase (e.g. observational)
Conditions: Disorder Heart Postoperative Cardiac Surgery

Sponsor: Unity Health Toronto

trial.available_in: БГ
Overview
TRICS-IV is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in moderate to high risk patients who are 65 years of age or younger undergoing cardiac surgery on cardiopulmonary bypass, using a superiority trial design.
Who can participate
Inclusion Criteria: 1. ≥18 and ≤65 years of age 2. Planned cardiac surgery using cardiopulmonary bypass 3. Informed consent obtained 4. Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more Exclusion Criteria: 1. Patients who refuse participation 2. Patients who are unable to receive or who refuse blood products 3. Patients who are involved in a preoperative autologous pre-donation program 4. Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device 5. Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomization for women of childbearing potential)
Locations 16
Australia (1)
Royal Adelaide Hospital
Adelaide , Adelaide
Canada (1)
University of Alberta Hospital
Edmonton , Alberta
Colombia (1)
Hospital Universitario San Ignacio
Bogotá
Edgar Rios, MD
Egypt (1)
Nasr City Health Insurance Hospital
Naşr , Cairo Governorate
ACTIVE_NOT_RECRUITING
Greece (1)
Democritus University of Thrace
Alexandroupoli , Evros
India (1)
EPIC Hospital
Ahmedabad , Gujarat
Namibia (1)
Windhoek Central Hospital
Windhoek , Khomas Region
ACTIVE_NOT_RECRUITING
Nepal (1)
Shahid Gangalal National Heart Center
Kathmandu , Kathmandu
Romania (1)
Emergency Institute of Cardiovascular Diseases
Bucharest , Romania
Russia (1)
Saint-Petersburg State University Hospital
Saint Petersburg
SUSPENDED
Singapore (1)
National Heart Centre
Singapore
South Africa (1)
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg , Gauteng
ACTIVE_NOT_RECRUITING
Spain (1)
Hospital de la Santa Creu I Sant Pau
Barcelona , Catalonia
Switzerland (1)
Inselspital, University Hospital Bern, University of Bern
Bern , Canton of Bern
United Kingdom (1)
University Hospital Leicester
Leicester , East Midlands
United States (1)
Maine Medical Center
Portland , Maine
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
01.11.2021
Completion date
01.06.2026
Registry ID
NCT04754022
Source
anzctr
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