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Blood Transfusion Strategies During Major Surgery

ConditionPerioperative Red Blood Cell Transfusion
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Restrictive Transfusion

    Procedure/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 transfusion

    Procedure/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.

Treatment groups

5,058 Participants
are divided into 2 treatment groups
Group A: Restrictive transfusion strategyExperimental treatment 1 intervention
Group B: Liberal transfusion strategyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

30-day overall morbidity or mortality

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.

Time frame
From randomization to 30 days post-surgery

Secondary outcomes

1

30-day individual perioperative complications

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.

Time frame
From randomization to 30 days post-surgery
2

90-day mortality

All-cause mortality within 90 days after surgery, assessed through participant follow-up and review of the medical record.

Time frame
From randomization to 90 days post-surgery
3

Blood product transfusions (intraoperative and postoperative)

Number of and type of blood product transfusions

Time frame
From randomization to 30 days post-surgery
4

Change in hemoglobin

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).

Time frame
From preoperative to 30 days post-surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ottawa Hospital Research Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: