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Can a higher transfusion threshold save lives in the operating room?

NCT ID NCT07748663

Disease control Sponsor: Ottawa Hospital Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This trial asks whether giving blood transfusions to keep hemoglobin levels higher (90-100 g/L) during and right after major surgery reduces serious complications or death within 30 days, compared to a lower threshold (70-80 g/L). About 5,000 adults at risk of needing a transfusion will be randomly assigned to one of the two strategies. Participants will also report their recovery and quality of life at 30 and 90 days after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Red blood cell transfusion
What this could lead to
If a higher transfusion threshold proves better, it could guide safer blood use during major surgery, potentially reducing complications and deaths.
What could go wrong
The trial is large but results may not apply to all surgeries or patients. Transfusions carry risks like reactions or infections, and the higher threshold might lead to more transfusions without clear benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 5,058 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 2035

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult patients, age ≥18. * Elective or urgent surgery. * Risk of red blood cell transfusion of at least 10 percent. * Preoperative hemoglobin of less than 130 g/L. * Intraoperative hemoglobin of \< 100 g/L at any time during surgery. Exclusion Criteria: * Active major hemorrhage as indication for surgery (e.g. ruptured aneurysm, polytrauma, etc.) * Acute coronary syndrome or myocardial infarction within the past 6 weeks. * Cardiac surgery, lung transplantation, or liver transplantation as the indication for surgery (a history of such surgery is allowed) * Surgery for moderate to severe (Glasgow Coma Scale (GCS) score ≤ 12) traumatic brain injury * Sickle cell disease (sickle cell trait is allowed) * Pregnancy or obstetrical surgery * Patient refusal of blood products * Inability to provide consent * Previous randomization in the TOPGUN(-Pilot) trial

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Perioperative red blood cell transfusion

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec, Canada

  • The Ottawa Hospital

    Ottawa, Ontario, Canada