The TOPGUN Trial: Threshold for Operative and Postoperative Hemoglobin Trigger for Red Blood Cell Transfusion
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5,058
- 试验地点
- 2
- 主要终点
- 30-day overall morbidity or mortality
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, age ≥
- •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.
排除标准
- •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
研究组 & 干预措施
Restrictive transfusion strategy
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.
干预措施: Restrictive Transfusion (Procedure)
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.
干预措施: Liberal transfusion (Procedure)
结局指标
主要结局
30-day overall morbidity or mortality
时间窗: 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.
次要结局
- 30-day individual perioperative complications(From randomization to 30 days post-surgery)
- 90-day mortality(From randomization to 90 days post-surgery)
- Blood product transfusions (intraoperative and postoperative)(From randomization to 30 days post-surgery)
- Change in hemoglobin(From preoperative to 30 days post-surgery)
- Estimated blood loss(During surgery)
- Intensive care admission(From randomization to 30 days post-surgery)
- Post-operative length of stay(From randomization to hospital discharge (up to 30 days post-surgery))
- Readmission to hospital(From discharge to 30 days post-surgery)
- Patient-reported disability(30 and 90 days post-surgery)
- Patient-reported quality of life(30 and 90 days post-surgery)
- Disease-free and overall survival (participants undergoing cancer resection)(3 and 5 years post-surgery)