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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04754022




Registration number
NCT04754022
Ethics application status
Date submitted
9/02/2021
Date registered
15/02/2021
Date last updated
25/02/2022

Titles & IDs
Public title
Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery
Scientific title
An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Younger Patients Undergoing Cardiac Surgery
Secondary ID [1] 0 0
TRICS-IV
Universal Trial Number (UTN)
Trial acronym
TRICS-IV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disorder 0 0
Heart 0 0
Postoperative 0 0
Cardiac Surgery 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Restrictive Transfusion Strategy
Other interventions - Liberal transfusion strategy

Active Comparator: 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.

Active Comparator: 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.


Other interventions: 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 interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
Within 6 months after cardiac surgery.
Secondary outcome [1] 0 0
Incidence of each individual component of the primary outcome: all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).
Timepoint [1] 0 0
Within 6 months after cardiac surgery.
Secondary outcome [2] 0 0
Composite and individual all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).
Timepoint [2] 0 0
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Secondary outcome [3] 0 0
Length of stay in the ICU and hospital.
Timepoint [3] 0 0
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Secondary outcome [4] 0 0
Prolonged low output state.
Timepoint [4] 0 0
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Secondary outcome [5] 0 0
Duration of mechanical ventilation.
Timepoint [5] 0 0
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Secondary outcome [6] 0 0
Incidence of infection.
Timepoint [6] 0 0
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Secondary outcome [7] 0 0
Acute kidney injury.
Timepoint [7] 0 0
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Secondary outcome [8] 0 0
Delirium.
Timepoint [8] 0 0
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Secondary outcome [9] 0 0
Incidence of gut infarction.
Timepoint [9] 0 0
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Secondary outcome [10] 0 0
Hospital visits.
Timepoint [10] 0 0
Within 6 months after cardiac surgery.
Secondary outcome [11] 0 0
Transfusion requirements.
Timepoint [11] 0 0
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Secondary outcome [12] 0 0
Incidence of seizures.
Timepoint [12] 0 0
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Secondary outcome [13] 0 0
Incidence of encephalopathy.
Timepoint [13] 0 0
Up to hospital discharge or after 28 days postoperatively, whichever comes first.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2024
Actual
Sample size
Target
1440
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
Country [2] 0 0
Canada
State/province [2] 0 0
New Brunswick
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
Russian Federation
State/province [5] 0 0
Saint Petersburg

Funding & Sponsors
Primary sponsor type
Other
Name
Unity Health Toronto
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04754022
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
David Mazer, MD
Address 0 0
Unity Health Toronto
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04754022