Threshold for Operative and Postoperative Hemoglobin Trigger for Red Blood Cell Transfusion: A Pilot Randomized Controlled Trial (TOPGUN-Pilot)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
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.
详细描述
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.
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.
- •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.
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.
干预措施: Liberal transfusion (Procedure)
结局指标
主要结局
Recruitment rate
时间窗: 12 months post site initiation
Recruitment of ≥8 patients per month per site for one year.
Intervention adherence
时间窗: From enrollment up to 6 hours in the Post-Anesthetic Care Unit
Intervention adherence of at least 85%.
Participant retention
时间窗: From randomization to 30 days post surgery.
Retention of at least 90% of participants with completion of 30-day effectiveness outcomes.
次要结局
未报告次要终点