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Clinical Trials in India / NCT04754022
Recruiting Not applicable

Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery

NCT04754022 · tracked via the Priya Life Science India tracker
Sponsor
Unity Health Toronto
Phase
Not applicable
Started
2021-11-01
Last updated
2024-11-21

Condition(s) studied

DisorderHeartPostoperativeCardiac Surgery

Investigational drug(s) / intervention(s)

Restrictive Transfusion StrategyLiberal transfusion strategy

Restrictive Transfusion Strategy: Patients will receive a RBC transfusion if their Hb concentration is \<75 g/L (\<7.5 g/dL; \<4.7mmol/L) intraoperatively and/or postoperatively.

Liberal transfusion strategy: Patients will receive a RBC transfusion if their Hb concentration is \<95 g/L (\<9.5 g/dL; \<5.9mmol/L) intraoperatively, or postoperatively in the ICU; and/or \<85 g/L (\< 8.5 g/dL; \<5.3mmol/L) on the ward.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (54)

FacilityCityRegionStatus
Maine Medical Center Portland Maine Recruiting
The Cooper Health System Camden New Jersey Recruiting
Columbia University New York New York Not Yet Recruiting
Thomas Jefferson University Philadelphia Pennsylvania Active Not Recruiting
Royal Adelaide Hospital Adelaide Adelaide Recruiting
Royal Prince Alfred hospital Camperdown New South Wales Recruiting
Prince of Wales Hospital Randwick New South Wales Recruiting
Westmead Hospital Westmead New South Wales Recruiting
Gold Coast University Hospital Southport Queensland Recruiting
Flinders Medical Centre Bedford Park South Australia Recruiting
Monash Health Clayton Victoria Recruiting
St Vincent's Hospital Melbourne Fitzroy Victoria Recruiting
Austin Health Heidelberg Victoria Recruiting
Royal Melbourne Hospital Melbourne Australia Recruiting
Alfred Hospital Prahran Australia Recruiting
University of Alberta Hospital Edmonton Alberta Recruiting
Interior Health Kelowna General Hospital Kelowna British Columbia Recruiting
Vancouver General Hospital Vancouver British Columbia Recruiting
Saint John Regional Hospitall Saint John New Brunswick Recruiting
Health Sciences North Research Institute Greater Sudbury Ontario Recruiting
Hamilton Health Sciences Centre / Hamilton General Hospital Hamilton Ontario Recruiting
Kingston Health Sciences Centre Kingston Ontario Active Not Recruiting
Sunnybrook Health Sciences Center Toronto Ontario Recruiting
St. Michael's Hospital, Unity Health Toronto Toronto Ontario Recruiting
Toronto General Hospital Toronto Ontario Recruiting
Montreal Heart Institute Montreal Quebec Recruiting
Centre hospitalier de l'Université de Montréal Montreal Quebec Recruiting
Jewish General Hospital Montreal Quebec Recruiting
Hôpital Sacré-Cœur de Montréal Montreal Quebec Recruiting
Institut universitaire de cardiologie et de pneumology de Québec - université Laval (IUCPQ-UL) Québec Quebec Recruiting
Hospital Universitario San Ignacio Bogotá Colombia Recruiting
Fundacion Abood Shaio Bogotá Colombia Recruiting
Fundacion Cardioinfantil Bogotá Colombia Recruiting
Nasr City Health Insurance Hospital Naşr Cairo Governorate Active Not Recruiting
Democritus University of Thrace Alexandroupoli Evros Recruiting
EPIC Hospital Ahmedabad Gujarat Recruiting
Windhoek Central Hospital Windhoek Khomas Region Active Not Recruiting
Shahid Gangalal National Heart Center Kathmandu Kathmandu Recruiting
Emergency Institute of Cardiovascular Diseases Bucharest Romania Recruiting
Saint-Petersburg State University Hospital Saint Petersburg Russia Suspended

+ 14 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04754022 on ClinicalTrials.gov ↗ ← All trials in India