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Blood Transfusion Strategies During Major Surgery (TOPGUN)

31. juli 2026 opdateret af: Ottawa Hospital Research Institute

The TOPGUN Trial: Threshold for Operative and Postoperative Hemoglobin Trigger for Red Blood Cell Transfusion

The goal of this randomized clinical trial is to address the uncertainty surrounding blood transfusion strategies in the operating room for adult patients undergoing major surgery. The main question it aims to answer is:

Does a higher hemoglobin threshold for blood transfusion during surgery reduce the risk of serious complications or death after surgery compared with a lower hemoglobin threshold?

Researchers will compare a liberal and a restrictive transfusion strategy during surgery and the first few hours of recovery.

Participants will be randomly assigned to one of two blood transfusion strategies. Blood transfusions will be given to maintain either a higher hemoglobin level (90-100 g/L) or a lower hemoglobin level (70-80 g/L) during surgery and while in the recovery room after surgery. Participants will also complete questionnaires about their quality of life and recovery at 30 and 90 days after surgery.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

5058

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada
        • The Ottawa Hospital
        • Kontakt:
    • Quebec
      • Montreal, Quebec, Canada
        • Centre Hospitalier de l'Université de Montréal

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Restriktiv transfusionsstrategi
Den restriktive transfusionsstrategi vil bestå af indgivelse af transfusion af røde blodlegemer, når deltagerens hæmoglobinniveau er målt under 70 g/L eller for at opretholde et hæmoglobinmålområde på 70-80 g/L.
Procedure: Restriktiv transfusion
Transfusion af røde blodlegemer, når deltagerens hæmoglobinniveau er målt under 70 g/L eller for at opretholde et hæmoglobinmålområde på 70-80 g/L. Denne strategi vil blive overholdt under operationen og op til 6 timer i den postoperative anæstesiafdeling.
Eksperimentel: Liberal transfusion strategy
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.ed to during surgery and up to 6 hours in the post-operative anesthesia care unit.
Procedure: Liberal transfusion
Transfusion af røde blodlegemer, når deltagerens hæmoglobinniveau er målt under 90 g/L eller for at opretholde et hæmoglobinmålområde på 90-100 g/L. Denne strategi vil blive overholdt under operationen og op til 6 timer i den postoperative anæstesiafdeling.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
30-day overall morbidity or mortality
Tidsramme: From randomization to 30 days post-surgery
Overall postoperative morbidity and mortality within 30 days after surgery, assessed using the Comprehensive Complication Index (CCI). Complications will be identified using the Postoperative Morbidity Survey (POMS) and graded according to the Clavien-Dindo classification. The CCI summarizes all postoperative complications into a continuous score ranging from 0 (no complications) to 100 (death), with higher scores indicating greater postoperative morbidity.
From randomization to 30 days post-surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
30-day individual perioperative complications
Tidsramme: From randomization to 30 days post-surgery
The occurrence of individual perioperative complications will be captured using the Postoperative Morbidity Survey (POMS). Complications will be categorized according to the POMS domains, including pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, wound, hematological, and pain-related morbidity.
From randomization to 30 days post-surgery
90-day mortality
Tidsramme: From randomization to 90 days post-surgery
All-cause mortality within 90 days after surgery, assessed through participant follow-up and review of the medical record.
From randomization to 90 days post-surgery
Blood product transfusions (intraoperative and postoperative)
Tidsramme: From randomization to 30 days post-surgery
Number of and type of blood product transfusions
From randomization to 30 days post-surgery
Change in hemoglobin
Tidsramme: From preoperative to 30 days post-surgery
Change in hemoglobin concentration from preoperative baseline through the perioperative and postoperative period, assessed using routine laboratory measurements and reported in grams per liter (g/L).
From preoperative to 30 days post-surgery
Estimated blood loss
Tidsramme: During surgery
Estimated blood loss in mL as noted in the operative report or anesthesia record
During surgery
Intensive care admission
Tidsramme: From randomization to 30 days post-surgery
Occurrence of admission to an intensive care unit (ICU)
From randomization to 30 days post-surgery
Post-operative length of stay
Tidsramme: From randomization to hospital discharge (up to 30 days post-surgery)
Number of days from the date of surgery to the date of discharge from the index hospitalization
From randomization to hospital discharge (up to 30 days post-surgery)
Readmission to hospital
Tidsramme: From discharge to 30 days post-surgery
Occurrence of readmission to a hospital
From discharge to 30 days post-surgery
Patient-reported disability
Tidsramme: 30 and 90 days post-surgery
Functional status and disability will be assessed using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). The WHODAS 2.0 evaluates functioning across six domains: cognition, mobility, self-care, getting along with others, life activities, and participation in society. Higher scores indicate greater disability and functional impairment.
30 and 90 days post-surgery
Patient-reported quality of life
Tidsramme: 30 and 90 days post-surgery
Patient-reported health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The EQ-5D-5L evaluates mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
30 and 90 days post-surgery
Disease-free and overall survival (participants undergoing cancer resection)
Tidsramme: 3 and 5 years post-surgery
For participants undergoing cancer resection, disease-free survival and overall survival will be assessed at 3 and 5 years after surgery through review of the electronic medical record.
3 and 5 years post-surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ottawa Hospital Research Institute

Efterforskere

  • Ledende efterforsker: Daniel McIsaac, MD, The Ottawa Hospital
  • Ledende efterforsker: Guillaume Martel, MD, MSc, FRCSC, FACS, Ottawa Hospital Research Institute

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

19. august 2026

Primær færdiggørelse (Anslået)

31. marts 2030

Studieafslutning (Anslået)

31. marts 2035

Datoer for studieregistrering

Først indsendt

31. juli 2026

Først indsendt, der opfyldte QC-kriterier

31. juli 2026

Først opslået (Faktiske)

6. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • CTO 5736
  • 20260417-01T (Anden identifikator: OHSN-REB)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Coded individual participant data from this study will be made available upon reasonable request.

IPD-delingstidsramme

After publication

IPD-delingsadgangskriterier

Qualified researchers may access coded individual participant data and relevant supporting study documents upon reasonable request. Requests must be submitted to the Principal Investigator and include a detailed research proposal.

Access will be subject to review and approval by the Study Steering Committee, institutional review boards (if applicable), and execution of a signed data access agreement.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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