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?

This trial explores two strategies for administering blood transfusions during surgery. The aim is to determine the practicality of a larger study comparing these methods. One group will receive liberal transfusions when hemoglobin (a protein in red blood cells that carries oxygen) drops below a certain level, while the other group will receive restrictive transfusions only when it drops even lower. The study seeks adults undergoing surgery who have a significant risk of needing a blood transfusion. As an unphased trial, it offers patients the opportunity to contribute to important research that could enhance future surgical care.

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 prior data suggests that these transfusion strategies are safe for surgery?

Research has shown that both giving more blood transfusions (liberal strategy) and giving fewer (restrictive strategy) are generally safe for surgery patients. One study found that the chances of major issues like death or heart problems were almost the same for both groups: 9.1% for those who received more transfusions and 10.1% for those who received fewer.

Other studies have found that giving fewer transfusions is just as effective as giving more. In some cases, it even slightly reduced the risk of heart failure and irregular heartbeats. Overall, both methods are safe and well-tolerated for people undergoing surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing liberal and restrictive blood transfusion strategies because it could redefine how we manage blood transfusions during surgery. Unlike the traditional approach, which often lacks precise thresholds, the liberal strategy involves transfusing when hemoglobin levels drop below 90 g/L to maintain a range between 90-100 g/L. In contrast, the restrictive strategy sets a lower threshold, transfusing only when levels fall below 70 g/L, maintaining a range between 70-80 g/L. By comparing these two distinct methods, researchers aim to determine the optimal transfusion strategy that balances patient safety with effective resource use, potentially leading to more personalized and efficient care.

What evidence suggests that this trial's transfusion strategies could be effective?

This trial will compare two blood transfusion strategies for surgery: a liberal transfusion strategy and a restrictive transfusion strategy. Research has shown benefits and drawbacks to both approaches. The liberal strategy, which participants in this trial may receive, involves giving blood transfusions when hemoglobin levels drop below 90 g/L. This approach may reduce the risk of heart attacks in the hospital for some heart patients but does not significantly improve survival rates 90 days after surgery. In contrast, the restrictive strategy, another option in this trial, provides transfusions when hemoglobin levels fall below 70 g/L. This method uses less blood and does not increase the risk of death or complications after surgery. Some studies suggest that restrictive strategies may lead to fewer combined health issues compared to liberal strategies, especially in older patients. Each approach has its strengths, so the choice may depend on the specific needs and conditions of the patient. ^{1 6 7 8 9}

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 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 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]

Citations

1. acc.org acc.org/latest-in-cardiology/articles/2025/11/03/16/19/sat-457pm-top-aha-2025

TOP: Does Liberal Transfusion Post Surgery Improve ... A liberal transfusion strategy following major vascular or general surgery did not significantly improve outcomes at 90 days post procedure ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11409761/

Comparison of liberal versus restrictive transfusion ... This study demonstrated that a liberal transfusion strategy tends to reduce the incidence of in-hospital myocardial infarction events in patients with coronary ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1711818

Restrictive or Liberal Red-Cell Transfusion for Cardiac ... The restrictive transfusion strategy was associated with a lower risk of the composite outcome than the liberal strategy among patients 75 years ...

4. ashpublications.org ashpublications.org/blood/article/146/6/661/537046/Counterpoint-the-design-and-interpretation-of

the design and interpretation of blood transfusion randomized ... The primary outcome of 30-day all-cause mortality was 18.7% in the restrictive strategy, and 23.3% in the liberal strategy (absolute difference, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0007091217311108

Liberal transfusion strategy improves survival in ... They found an extensive evidence base, and the data indicated that a liberal transfusion strategy was associated with improved survival in perioperative (but ...

6. tctmd.com tctmd.com/news/liberal-transfusion-doesnt-decrease-mace-surgery-patients-high-cardiac-risk-top

Liberal Transfusion Doesn't Decrease MACE in Surgery ... Mortality/major ischemic events at 90 days were no lower than with a restrictive strategy—but cardiac complications differed.

7. jamanetwork.com jamanetwork.com/journals/jama/article-abstract/2841245

Liberal or Restrictive Postoperative Transfusion in Patients ... The primary outcome rate was similar in both groups (9.1% in the liberal group vs 10.1% in the restrictive group).

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41205227/

Liberal or Restrictive Postoperative Transfusion in Patients ... Objective: To evaluate the risk of death or major ischemic events within 90 days after a liberal transfusion strategy compared with a ...

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa1012452

Liberal or Restrictive Transfusion in High-Risk Patients ... The rates of the primary outcome were 35.2% in the liberal-strategy group and 34.7% in the restrictive-strategy group (odds ratio in the liberal ...