Comparing Restrictive Transfusion Strategy with Liberal transfusion strategy for disorder
Official title: Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery
An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Younger Patients Undergoing Cardiac Surgery
- 2 groups
- Sites in Edmonton, Kelowna and 8 more cities
- Recruiting
Interventions
- Other intervention
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.
- Other intervention
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.
Canadian Sites (15)
14 of 15 recruiting
- 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
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
- Not currently recruiting
Kingston Health Sciences Centre
Kingston, Ontario
Eligibility Criteria
See who this study is looking for9 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +≥18 and ≤65 years of age
- +Informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → obtained
- +Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more
- +Planned cardiac surgery using cardiopulmonary bypass
Exclusion
- −Patients who refuse participation
- −Patients who are unable to receive or who refuse blood products
- −Patients who are involved in a preoperative autologous pre-donation program
- −Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → for women of childbearing potential)
- −Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives Restrictive Transfusion Strategy.
Registry label: A: Restrictive Transfusion Strategy
Group B, the comparison group, receives Liberal transfusion strategy.
Registry label: B: Liberal Transfusion Strategy
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 65 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,440 people.
The study is currently expected to finish around June 2026.
The main measurement is taken over: Within 6 months after cardiac surgery.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Composite score of any one of the following events occurring 6 months after cardiac surgery: (1) all-cause mortality; (2) myocardial infarction; (3) new onset renal failure requiring dialysis; or (4) new focal neurological deficit (stroke) — measured over Within 6 months after cardiac surgery.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04754022 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Restrictive Transfusion StrategyOther
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.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Liberal transfusion strategyOther
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.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 65 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 65 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Within 6 months after cardiac surgery..
The study as a whole is currently expected to finish around 2026-06.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,440 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 11 locations, including: Edmonton, Alberta, Canada; Kelowna, British Columbia, Canada; Vancouver, British Columbia, Canada; Saint John, New Brunswick, Canada; Greater Sudbury, Ontario, Canada; Hamilton, Ontario, Canada, and 5 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (1)
Columbia University
New York, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.