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Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Restrictive Transfusion Strategy (other), Liberal transfusion strategy (other)
How long the study runs: Study runs about 55 months (dates as stated)
About the drug or intervention: Restrictive Transfusion Strategy — other: 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 — other: 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.
Patient visit burden: Not specified by the sponsor

In plain English

This study looks at blood transfusion needs in younger patients (aged 18 to 65) having heart surgery with a heart-lung bypass machine. All patients in the study have a higher predicted risk around their operation, based on a risk score called EuroSCORE I of 6 or more. The sponsor is Unity Health Toronto.

Who can take part

Aged 18 to 65
Having planned heart surgery that uses a heart-lung bypass machine
Given informed consent to take part
A pre-operative risk score (EuroSCORE I) of 6 or more

Who may not be able to

Those who choose not to take part
Those who cannot or do not want to receive blood products
Those already taking part in a programme to donate their own blood before surgery
Those having a heart transplant or surgery only to put in a ventricular assist device (a pump that helps the heart)
Those who are pregnant or breastfeeding (women who could become pregnant need a negative pregnancy test before joining)

What taking part involves

• Not stated — ask the trial team

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study: Testing a treatment
Ages: 18 Years to 65 Years
Who: All
Number of participants: 1,440
Started: 2021-11-01
Last checked: 2024-11

Plain English Summary

What is this study?

• Testing a new treatment for disorder
• NA - 1,440 participants
• 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 take part?

• Ages 18 Years to 65 Years
• Diagnosed with disorder

Where?

• Leicester - University Hospital Leicester
• Basildon - Basildon University Hospitals-Mid and South Essex NHS Trust
• Southampton - University Hospital Southampton Foundation Trust
• Brighton - University Hospitals Sussex NHS Foundation Trust
• +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

DisorderHeartPostoperativeCardiac Surgery

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years - 65 Years
Who can join: All genders

What the study is looking for

✓≥18 and ≤65 years of age
✓Planned heart surgery using cardiopulmonary bypass
✓agreement to take part obtained
✓Preoperative European System for heart Operative Risk Evaluation (EuroSCORE I) of 6 or more

Who cannot take part

✗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
✗Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device
✗Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomization for women of childbearing...

See the full criteria

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)