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Transfusion Strategies for Cardiac Surgery Patients (TRICS-IV Trial)

Q: What is the maximum capacity of patients for this medical experiment?

That is correct. Clinicaltrials.gov documents that this investigation, which was initially posted on November 1st 2021, remains ongoing and is currently recruiting participants. 1440 patients need to be recruited from 6 separate medical sites.

Q: Might I be a suitable participant for this clinical experiment?

This study is taking in 1440 individuals with heart conditions, aged 18-65. Most notably, applicants must meet the following prerequisites: between 18 and 65 years of age; Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or above; Scheduled cardiac surgery involving cardiopulmonary bypass.

Q: Is the age range for this trial participants extending beyond 45 years?

This medical trial seeks adult patients between the ages of 18 and 65.

Q: Are there multiple institutions in the United States administering this clinical trial?

Currently, six medical centres are looking to enlist participants for this trial including Centre hospitalier de l'Université de Montréal in Montreal, Saint John Regional Hospital in Saint John, and Hamilton Health Sciences Center / Hamilton General Hospital in Hamilton. Additionally there are other recruiting sites scattered across the country.

Q: Are potential candidates still being accepted for this trial?

According to the data published on clinicaltrials.gov, recruitment for this medical experiment is still ongoing. It has been active since November 1st 2021 and was last updated February 24th 2022.

N/A

Waitlist Available

Led By David Mazer, MD

Research Sponsored by Unity Health Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to hospital discharge or after 28 days postoperatively, whichever comes first.

Awards & highlights

TRICS-IV Trial Summary

This trial is testing two different transfusion strategies in young cardiac surgery patients to see which is better.

Who is the study for?

This trial is for younger patients (18-65 years old) with a moderate to high risk of complications from cardiac surgery, as indicated by a EuroSCORE I of 6 or more. They must be undergoing heart surgery that requires cardiopulmonary bypass and able to give informed consent. It's not for those who refuse blood products, are in certain pre-surgery donation programs, need a heart transplant or ventricular assist device alone, or women who are pregnant or breastfeeding.Check my eligibility

What is being tested?

The TRICS-IV study compares two blood transfusion strategies during cardiac surgery: 'Restrictive' gives fewer transfusions based on specific criteria while 'Liberal' provides them more freely. Patients will be randomly assigned to one of these approaches to see which is superior for those under 65 at higher surgical risk.See study design

What are the potential side effects?

Potential side effects may include reactions related to blood transfusions such as fever, allergic responses, lung injury, and in rare cases infections or immune system effects. The risks vary depending on the strategy used and individual patient factors.

TRICS-IV Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to hospital discharge or after 28 days postoperatively, whichever comes first.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to hospital discharge or after 28 days postoperatively, whichever comes first.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to hospital discharge or after 28 days postoperatively, whichever comes first. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome 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).

Secondary outcome measures

Acute kidney injury.

Composite and individual all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).

Delirium.

+10 more

TRICS-IV Trial Design

2Treatment groups

Active Control

Group I: Restrictive Transfusion StrategyActive Control1 Intervention

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.

Group II: Liberal Transfusion StrategyActive Control1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor

544 Previous Clinical Trials

449,002 Total Patients Enrolled

David Mazer, MDPrincipal InvestigatorUnity Health Toronto

10 Previous Clinical Trials

6,828 Total Patients Enrolled

Nadine Shehata, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL

3 Previous Clinical Trials

5,286 Total Patients Enrolled

Media Library

Liberal transfusion strategy Clinical Trial Eligibility Overview. Trial Name: NCT04754022 — N/A

Heart Research Study Groups: Restrictive Transfusion Strategy, Liberal Transfusion Strategy

Heart Clinical Trial 2023: Liberal transfusion strategy Highlights & Side Effects. Trial Name: NCT04754022 — N/A

Liberal transfusion strategy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04754022 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum capacity of patients for this medical experiment?

"That is correct. Clinicaltrials.gov documents that this investigation, which was initially posted on November 1st 2021, remains ongoing and is currently recruiting participants. 1440 patients need to be recruited from 6 separate medical sites."

Answered by AI

Might I be a suitable participant for this clinical experiment?

"This study is taking in 1440 individuals with heart conditions, aged 18-65. Most notably, applicants must meet the following prerequisites: between 18 and 65 years of age; Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or above; Scheduled cardiac surgery involving cardiopulmonary bypass."

Answered by AI

Is the age range for this trial participants extending beyond 45 years?

"This medical trial seeks adult patients between the ages of 18 and 65."

Answered by AI

Are there multiple institutions in the United States administering this clinical trial?

"Currently, six medical centres are looking to enlist participants for this trial including Centre hospitalier de l'Université de Montréal in Montreal, Saint John Regional Hospital in Saint John, and Hamilton Health Sciences Center / Hamilton General Hospital in Hamilton. Additionally there are other recruiting sites scattered across the country."

Answered by AI

Are potential candidates still being accepted for this trial?

"According to the data published on clinicaltrials.gov, recruitment for this medical experiment is still ongoing. It has been active since November 1st 2021 and was last updated February 24th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery

2021. "Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04754022.