Blood Transfusion Strategies for Surgery

(TOPGUN-Pilot Trial)

Overseen By Zanna Vanterpool, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Active hemorrhage, Recent MI, Cardiac surgery, Liver transplant, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: During surgery

384 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this pilot clinical trial is to learn if it is achievable to conduct a large-scale clinical trial whereby, the investigators will compare two ways of deciding when to give a blood transfusion during surgery. Participants in this study are adults undergoing surgery with a risk of significant blood loss. The main question it aims to answer is: * Is a trial designed to definitively test and compare two different red blood cell transfusion strategies feasible? Participants will: * Receive blood transfusions during surgery based on a higher (less than 90 g/L) or a lower (less than 70 g/L) hemoglobin value. * Complete questionnaires at 30 and 90 days after 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.

Is blood transfusion generally safe for surgery patients?

Blood transfusions are common in surgery, and while they can cause reactions and complications, newer methods have made them safer. Restrictive transfusion strategies, which use less blood, are often as safe or safer than using more blood, especially in cardiac surgery. ^{1 2 3 4 5}

How do liberal and restrictive transfusion treatments differ from other treatments for surgery?

Liberal and restrictive transfusion treatments differ in the amount of blood given to patients during surgery; liberal transfusion involves giving more blood, while restrictive transfusion involves giving less. These strategies are unique because they focus on balancing the benefits and risks of blood transfusions, such as reducing the chance of infections or organ dysfunction, rather than using a one-size-fits-all approach. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment Liberal Transfusion, Restrictive Transfusion for surgery?

Research suggests that a liberal transfusion strategy may improve survival in patients undergoing surgery, while a restrictive strategy might reduce complications like infections in burn patients. However, there is no clear consensus for cardiac surgery, indicating that the effectiveness may vary depending on the specific surgical context. ^{2 6 8 9 10}

Who Is on the Research Team?

Guillaume Martel, MD, MSc, FRCSC, FACS

Principal Investigator

Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for adults who are undergoing surgery with a risk of significant blood loss. It's designed to see if it's possible to do a larger study on when to give blood transfusions during surgery based on different hemoglobin levels.

Inclusion Criteria

Preoperative hemoglobin of less than 130 g/L

I am scheduled for or have had a planned or urgent surgery.

I have a 10% or higher risk of needing a blood transfusion.

Exclusion Criteria

I have not had a heart attack or severe heart issue in the last 6 weeks.

I have had heart surgery.

I refuse to receive blood products.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive blood transfusions during surgery based on hemoglobin levels

During surgery

1 visit (in-person)

Postoperative Care

Participants are monitored in the Post-Anesthetic Care Unit for up to 6 hours

Up to 6 hours

Follow-up

Participants complete questionnaires at 30 and 90 days after surgery

90 days

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Liberal Transfusion
• Restrictive Transfusion

Trial Overview The study compares two transfusion strategies: one gives blood transfusions when hemoglobin drops below 90 g/L, and the other when it falls below 70 g/L. Participants will be randomly assigned to either strategy and followed up with questionnaires.

How Is the Trial Designed?

Group I: Restrictive transfusion strategy Experimental Treatment 1 Intervention

The restrictive transfusion strategy will consist of administering red blood cell transfusion when the participant's hemoglobin level is measured below 70 g/L or to maintain a hemoglobin target range of 70-80 g/L.

Group II: Liberal transfusion strategy Experimental Treatment 1 Intervention

The liberal transfusion strategy will consist of administering red blood cell transfusion when the participant's hemoglobin level is measured below 90 g/L or to maintain a hemoglobin target range of 90-100 g/L.

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Published Research Related to This Trial

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 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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Liberal transfusion strategy improves survival in perioperative but not in critically ill patients. A meta-analysis of randomised trials. [2018]

2. 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]

3. England pubmed.ncbi.nlm.nih.gov

Effects of restrictive red blood cell transfusion on the prognoses of adult patients undergoing cardiac surgery: a meta-analysis of randomized controlled trials. [2019]

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

Transfusion Requirement in Burn Care Evaluation (TRIBE): A Multicenter Randomized Prospective Trial of Blood Transfusion in Major Burn Injury. [2019]

5. China pubmed.ncbi.nlm.nih.gov

[Perioperative Restrictive Red Blood Cell Transfusion:Recent Advances in Research and Clinical Guidelines]. [2019]

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

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

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

Transfusion strategies in hematologic and nonhematologic disease. [2016]

9. India pubmed.ncbi.nlm.nih.gov

Adverse events related to blood transfusion. [2022]

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

Transfusion requirements in surgical oncology patients: a prospective, randomized controlled trial. [2022]