Transfusion Strategies for Cardiac Surgery Patients

(TRICS-IV Trial)

Recruiting in Palo Alto (17 mi)

+52 other locations

Overseen by David Mazer, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Unity Health Toronto

Disqualifiers: Refuse blood products, Heart transplant, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is studying different methods to help patients recover better after heart surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the transfusion strategies for cardiac surgery patients?

Research shows that using a restrictive transfusion strategy, which means giving blood only when absolutely necessary, is just as safe and effective as a liberal strategy, where more blood is given, for patients undergoing heart surgery. This approach can also reduce costs and avoid potential complications from unnecessary transfusions. ^{1 2 3 4 5}

Is it safe to use different blood transfusion strategies in cardiac surgery?

Research shows that using a restrictive blood transfusion strategy, which means giving less blood, is generally safe and sometimes better than giving more blood (liberal strategy) for patients undergoing cardiac surgery. However, there are known risks with blood transfusions, such as infections and lung issues, but these are often not reported. ^{1 3 4 6 7}

How do transfusion strategies differ for cardiac surgery patients?

The unique aspect of transfusion strategies in cardiac surgery is the comparison between 'restrictive' and 'liberal' approaches, where restrictive strategies aim to minimize blood transfusions to reduce risks like infections and lung injury, while liberal strategies involve more frequent transfusions. Despite mixed results, evidence suggests that restrictive strategies are at least as effective as liberal ones, potentially offering a safer option for patients. ^{1 3 4 8 9}

Research Team

Nadine Shehata, MD

Principal Investigator

MOUNT SINAI HOSPITAL

David Mazer, MD

Principal Investigator

Unity Health Toronto

Eligibility Criteria

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.

Inclusion Criteria

Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more

≥18 and ≤65 years of age

Planned cardiac surgery using cardiopulmonary bypass

Exclusion Criteria

You can't or won't receive 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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cardiac surgery with either a restrictive or liberal transfusion strategy

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

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of infection, acute kidney injury, and other secondary outcomes

Up to 6 months after cardiac surgery

Long-term follow-up

Monitoring of primary outcomes such as all-cause mortality, myocardial infarction, and new onset renal failure requiring dialysis

Within 6 months after cardiac surgery

Treatment Details

Interventions

• Liberal transfusion strategy (Other)
• Restrictive Transfusion Strategy (Other)

Trial Overview 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.

Participant Groups

Group I: Restrictive Transfusion Strategy Active Control 1 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 Strategy Active Control 1 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.

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

Dr. Sharon Straus

Unity Health Toronto

Chief Medical Officer

MD and MSc in Clinical Epidemiology, University of Toronto

Altaf Stationwala

Unity Health Toronto

Chief Executive Officer

Bachelor's degree in Health Administration, University of Ottawa

Findings from Research

In a review of ten trials involving 9,101 patients, a restrictive blood transfusion strategy in cardiac surgery did not significantly affect mortality rates compared to a liberal strategy, indicating it is a safe alternative.

The restrictive strategy led to a lower number of red blood cell transfusions without negatively impacting other clinical outcomes, suggesting it can effectively reduce the need for transfusions in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of restrictive versus liberal transfusion strategies on longer-term outcomes after cardiac surgery: a systematic review and meta-analysis with trial sequential analysis. Kashani, HH., Lodewyks, C., Kavosh, MS., et al.[2022]

A review of literature on blood transfusions in cardiac operations indicates that a restrictive transfusion policy is safe and effective, showing little difference in outcomes compared to a liberal policy while also reducing costs.

While many patients may not need transfusions, a small group of high-risk patients might benefit from a more liberal approach, although identifying these patients remains challenging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Case for a Conservative Approach to Blood Transfusion Management in Cardiac Surgery. Gunn, T., Paone, G., Emery, RW., et al.[2022]

Restrictive transfusion strategies, which involve lower hemoglobin thresholds for red cell transfusion, are not inferior to liberal strategies in patients undergoing cardiac surgery, suggesting they can be safely implemented.

Recent large randomized controlled trials have shown inconsistent results regarding hemoglobin levels and transfusion practices, but overall evidence supports the use of restrictive strategies to reduce risks of anemia and transfusion-related complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Red cell transfusion in cardiac surgery: what is the right balance? Shehata, N., Mazer, CD.[2019]

Excess blood transfusions during cardiac surgery can lead to serious complications such as infections, immune system issues, and lung injuries, which are often underreported and underestimated in their impact.

A restrictive transfusion strategy, which uses fewer transfusions, has been shown in randomized trials to be as effective or even better than a liberal transfusion strategy, yet it faces resistance in adoption within the cardiac surgical community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Conservation in Cardiac Surgery: In Need of a Transfusion Revolution. Varghese, R., Jhang, J.[2017]

In a study of 5243 adults undergoing cardiac surgery, a restrictive red-cell transfusion strategy was found to be noninferior to a liberal strategy regarding major adverse outcomes (death, myocardial infarction, stroke, or new-onset renal failure) at 6 months post-surgery.

Mortality rates were similar between the restrictive (6.2%) and liberal (6.4%) transfusion groups, indicating that a more conservative approach to transfusion does not compromise patient safety or outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six-Month Outcomes after Restrictive or Liberal Transfusion for Cardiac Surgery. Mazer, CD., Whitlock, RP., Fergusson, DA., et al.[2018]

A restrictive transfusion protocol, which only allows red blood cell transfusions for patients with hemoglobin levels below 6 g/dL or between 6 to 8 g/dL with specific conditions, was safely implemented in a study of 409 cardiac surgery patients across 30 centers.

The protocol resulted in excellent patient outcomes, with a low mortality rate of 0.49% and a significant portion (65.0%) of patients avoiding transfusions altogether, suggesting that this approach can effectively reduce unnecessary transfusions while maintaining safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe application of a restrictive transfusion protocol in moderate-risk patients undergoing cardiac operations. Song, HK., von Heymann, C., Jespersen, CM., et al.[2014]

A review of over 7000 patients in clinical trials indicates that a restrictive transfusion strategy (7-8 g/dL) is generally safe and may be superior to a liberal strategy (9-10 g/dL) for most patients.

However, for patients with specific conditions like myocardial infarction or stroke, more research is needed, as preliminary evidence suggests that a liberal transfusion strategy could be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transfusion strategies in hematologic and nonhematologic disease. Carson, JL., Strair, R.[2016]

A systematic review of four randomized controlled trials involving 454 pediatric cardiac surgery patients found no significant differences in clinical outcomes, such as ICU stay and hospital length, between restrictive and liberal red blood cell transfusion strategies.

The study suggests that restrictive transfusion thresholds are non-inferior to liberal thresholds in pediatric cardiac patients, indicating that a more conservative approach may be safe, but further high-quality research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Red blood cell transfusion threshold after pediatric cardiac surgery: A systematic review and meta-analysis. Deng, X., Wang, Y., Huang, P., et al.[2022]

In a study involving 5243 adults undergoing cardiac surgery, a restrictive red-cell transfusion strategy (transfusing at hemoglobin <7.5 g/dL) was found to be noninferior to a liberal strategy (transfusing at hemoglobin <9.5 g/dL) in terms of major clinical outcomes, such as death, myocardial infarction, stroke, or new-onset renal failure.

The restrictive strategy resulted in significantly fewer patients receiving blood transfusions (52.3% vs. 72.6%), suggesting it is a safer approach that conserves blood resources without compromising patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery. Mazer, CD., Whitlock, RP., Fergusson, DA., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

The effect of restrictive versus liberal transfusion strategies on longer-term outcomes after cardiac surgery: a systematic review and meta-analysis with trial sequential analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The Case for a Conservative Approach to Blood Transfusion Management in Cardiac Surgery. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Red cell transfusion in cardiac surgery: what is the right balance? [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Blood Conservation in Cardiac Surgery: In Need of a Transfusion Revolution. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Six-Month Outcomes after Restrictive or Liberal Transfusion for Cardiac Surgery. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Safe application of a restrictive transfusion protocol in moderate-risk patients undergoing cardiac operations. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Transfusion strategies in hematologic and nonhematologic disease. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

Red blood cell transfusion threshold after pediatric cardiac surgery: A systematic review and meta-analysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery. [2018]