Effects of Donor-recipient Sex-matched Versus Sex-mismatched Red Blood Cell Transfusion on Outcomes in Critically Ill Adult Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 11,082
- 试验地点
- 16
- 主要终点
- 30 day mortality
研究概览
简要总结
Red blood cell (RBC) transfusions are selected based upon matching donor and recipient blood group: donor and recipient sex are not considered when selecting blood for transfusion. Hence, transfused patients can currently receive sex-matched and/or unmatched RBCs when transfusions are given. Sex-matched stem cell transplants, and some solid organ transplants, have shown that sex-matching donor to recipient improves patient outcomes. Recent exploratory studies have also suggested that patient outcomes could be improved by sex-matching for RBC transfusion. There is emerging evidence of underlying biologic mechanism(s) to support these observations. This study is designed as a randomized controlled trial and will explore the impact on patients who receive RBC transfusions from donors of the same sex ("sex-matched") compared with donors of the opposite sex ("sex-mismatched").
The trial will study adult patients admitted to the Intensive Care Unit who require an RBC transfusion. Patients will be assigned (through a process called randomization) to receive sex-matched RBCs or sex-mismatched RBCs to determine if there is a difference in mortality between those receiving matched versus mismatched RBCs. The results of this trial could have direct implications on resources, blood inventory, and RBC transfusion ordering practices.
详细描述
Background: Red blood cell (RBC) transfusions are selected based upon donor and recipient blood group compatibility without consideration of donor and recipient sex. Stem cell transplants, and some solid organ transplants, have shown that sex-matching donor to recipient improves patient outcomes. The Principal Investigator has completed a systematic review/meta-analysis and a 40,000 patient exploratory analysis; both showed a signal of benefit from sex-matched RBC transfusion. Biological findings to support the hypothesis that sex-matched RBC transfusions improve survival in recipients are also emerging.
Controversial results have emerged from observational studies and a randomized controlled trial (RCT) regarding recipient mortality from sex-mismatched RBC transfusions; hence, equipoise exists.
The Principal Investigator completed a multisite pilot RCT that showed feasibility for conducting a large-scale RCT and has helped to inform design for this study proposal. The goal of this research project is to develop a precision transfusion strategy based on sex-matching of blood donor and recipient to minimize adverse effects and improve patient outcomes post-transfusion.
Overall Research Question: In transfused adult patients admitted to the Intensive Care Unit (ICU), do donor-recipient sex-matched RBC transfusions result in improved mortality compared to sex-mismatched RBC transfusions?
Methods: This study is a superiority RCT with pragmatic features that will occur across participating sites in Canada.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Site blood bank and transfusion officer.
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
- •Adults (age ≥18);
- •Admission to a participating ICU;
- •Requiring RBC transfusion.
排除标准
- •Requirement for a specialized RBC product or unit not readily available in inventory (e.g., rare blood type, washed RBCs, complex RBC antibodies, etc.);
- •Massively bleeding patient (i.e., ≥4 units of blood ordered at one time, or Massive Hemorrhage Protocol initiated, or an urgent blood request made);
- •Sex unknown or sex other than male or female (i.e. intersex);
- •Do not have a valid Ontario Health Insurance Plan (OHIP) health card number.
研究组 & 干预措施
Sex-matched
Sex-matched red blood cell transfusion
干预措施: Sex-matched red blood cell transfusions (Biological)
Sex-mismatched
Sex-mismatched red blood cell transfusion
干预措施: Sex-mismatched red blood cell transfusions (Biological)
结局指标
主要结局
30 day mortality
时间窗: From randomization to 30 days post-randomization.
Death within 30 days of randomization.
次要结局
- 30 day in-hospital mortality(From randomization to 30 days post-randomization.)
- 90 day mortality(From randomization to 90 days post-randomization.)
- Time to 30 day in-hospital mortality(From randomization to 30 days post-randomization.)
- Hemoglobin increment(From time of randomization until death or discharge from ICU; up to 90 days post randomization.)
- Need for renal replacement therapy(From time of randomization during ICU admission, until death or discharge from ICU; up to 90 days post randomization.)
- ICU/hospital length of stay(From randomization to 30 days post-randomization.)
- Number/type/volume/dose of transfused product(From randomization to 90 days post-randomization.)
- Transfusion reactions(From randomization to 30 days post-randomization.)
- Cost effectiveness(From randomization to 90 days post-randomization.)
研究者
Michelle Zeller
Associate Professor
McMaster University