Blood TransfusionTOPGUN-PilotNCT06718439
Hemoglobin Levels for Blood Transfusions During and After Surgery
A study testing Restrictive Transfusion and Liberal transfusion in people with Blood Transfusion and Surgery, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Transfusion, Surgery
- What is being tested?
- Restrictive Transfusion and Liberal transfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteCanada
- Study dates
- 16 Apr 2025to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Liver transplantation.
- Surgery for moderate to severe (Glasgow Coma Scale (GCS) score ≤ 12) traumatic brain injury.
- Pregnancy or obstetrical surgery.
- Patient refusal of blood products.
- Inability to provide consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Threshold for Operative and Postoperative Hemoglobin Trigger for Red Blood Cell Transfusion: A Pilot Randomized Controlled Trial (TOPGUN-Pilot)
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.
Read the detailed description
During some surgeries, there is a risk of significant blood loss. To manage this, blood transfusions may be needed to replace lost blood.
Transfusion strategies during surgery vary among physicians and hospitals. Current guidelines are broad and suggest it is okay to limit blood transfusions during surgery. However, some anesthesiologists worry that not giving enough blood might cause problems for patients. On the other hand, many cancer surgeons are concerned that giving too much blood could lead to worse outcomes for cancer patients. This difference in opinions shows why clinical trials are needed to guide future practices.
The purpose of this study is to test a new protocol that is designed to definitively test and compare two different red blood cell transfusion strategies. It is hypothesized that this trial will be deemed feasible.
TOPGUN-Pilot is a pragmatic, individually randomized, parallel-arm, vanguard, randomized controlled trial. If feasibility is demonstrated, patients enrolled in the vanguard pilot will be rolled into the definitive TOPGUN trial. This trial is meant to be pragmatic in nature, whereby the study protocol is simple to implement, outcomes are relevant to patients, physicians, and healthcare administrators, and data collection is limited. Management of patients prior to, during, and after the intraoperative transfusion strategies will be at the discretion of individual practitioners. A total of 384 patients will be randomized across 3 hospitals (4 sites) in Ontario and Quebec.
- Conditions
- Blood Transfusion, Surgery
- Being tested
- Restrictive Transfusion, Liberal transfusion
- Keywords
- Red blood cell transfusion, hemoglobin threshold, blood loss management, liberal transfusion practice, restrictive transfusion practice, intraoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restrictive TransfusionProcedure or surgery
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. This strategy will be adhered to during surgery and up to 6 hours in the post-operative anesthesia care unit.
Liberal transfusionProcedure or surgery
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. This strategy will be adhered to during surgery and up to 6 hours in the post-operative anesthesia care unit.
| Study group | Role | What they receive |
|---|---|---|
| Restrictive transfusion strategy | Experimental | 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. Receives: Procedure: Restrictive Transfusion |
| Liberal transfusion strategy | Experimental | 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. Receives: Procedure: Liberal transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Recruitment of ≥8 patients per month per site for one year.
Measured: 12 months post site initiation
Intervention adherence
Intervention adherence of at least 85%.
Measured: From enrollment up to 6 hours in the Post-Anesthetic Care Unit
Participant retention
Retention of at least 90% of participants with completion of 30-day effectiveness outcomes.
Measured: From randomization to 30 days post surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start16 Apr 2025
- Primary completion16 Sep 2026
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood TransfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Martel, MD, MSc, FRCSC, FACS, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718439
- Sponsor's protocol ID
- 20240690-01H
- Acronym
- TOPGUN-Pilot
- Status last verified
- Oct 2026
- First submitted
- 25 Nov 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Threshold for Operative and Postoperative Hemoglobin Trigger for Red Blood Cell Transfusion: A Pilot Randomized Controlled Trial (TOPGUN-Pilot)
- ClinicalTrials.gov ID
- NCT06718439
- Acronym / sponsor ID
- TOPGUN-Pilot / 20240690-01H
- Conditions
- Blood Transfusion, Surgery
- Keywords
- Red blood cell transfusion, hemoglobin threshold, blood loss management, liberal transfusion practice, restrictive transfusion practice, intraoperative
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 16 Sep 2026 (actual)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
During some surgeries, there is a risk of significant blood loss. To manage this, blood transfusions may be needed to replace lost blood.
Transfusion strategies during surgery vary among physicians and hospitals. Current guidelines are broad and suggest it is okay to limit blood transfusions during surgery. However, some anesthesiologists worry that not giving enough blood might cause problems for patients. On the other hand, many cancer surgeons are concerned that giving too much blood could lead to worse outcomes for cancer patients. This difference in opinions shows why clinical trials are needed to guide future practices.
The purpose of this study is to test a new protocol that is designed to definitively test and compare two different red blood cell transfusion strategies. It is hypothesized that this trial will be deemed feasible.
TOPGUN-Pilot is a pragmatic, individually randomized, parallel-arm, vanguard, randomized controlled trial. If feasibility is demonstrated, patients enrolled in the vanguard pilot will be rolled into the definitive TOPGUN trial. This trial is meant to be pragmatic in nature, whereby the study protocol is simple to implement, outcomes are relevant to patients, physicians, and healthcare administrators, and data collection is limited. Management of patients prior to, during, and after the intraoperative transfusion strategies will be at the discretion of individual practitioners. A total of 384 patients will be randomized across 3 hospitals (4 sites) in Ontario and Quebec.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restrictive transfusion strategy | Experimental | Procedure: Restrictive TransfusionThe 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. |
| Liberal transfusion strategy | Experimental | Procedure: Liberal transfusionThe 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
- Liver transplantation.
- Surgery for moderate to severe (Glasgow Coma Scale (GCS) score ≤ 12) traumatic brain injury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restrictive TransfusionRed 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. This strategy will be adhered to during surgery and up to 6 hours in the post-operative anesthesia care unit. | Procedure or surgery | Restrictive transfusion strategy |
| Liberal transfusionRed 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. This strategy will be adhered to during surgery and up to 6 hours in the post-operative anesthesia care unit. | Procedure or surgery | Liberal transfusion strategy |
Primary outcome
Recruitment rate
Time frame: 12 months post site initiation
Recruitment of ≥8 patients per month per site for one year.
Intervention adherence
Time frame: From enrollment up to 6 hours in the Post-Anesthetic Care Unit
Intervention adherence of at least 85%.
Participant retention
Time frame: From randomization to 30 days post surgery.
Retention of at least 90% of participants with completion of 30-day effectiveness outcomes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Martel, MD, MSc, FRCSC, FACS principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restrictive Transfusion and Liberal transfusion in people with Blood Transfusion and Surgery, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 12 months post site initiation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.