An Innovative Trial Assessing Donor Sex on Recipient Mortality (iTADS)
试验速览
- 阶段
- 4 期
- 入组人数
- 8,850
- 试验地点
- 2
- 主要终点
- Survival
研究概览
简要总结
The iTADS trial will test an important blood donor characteristic - donor sex - to see whether male donor blood leads to a greater benefit for transfusion recipients compared to female donor blood.
The trial will help determine how the investigators can tailor the selection of blood donors based on donor characteristics (e.g. sex) to further improve the safety and optimize the clinical benefit of blood products in Canada.
详细描述
The investigators have designed an innovative pragmatic randomized trial that will allocate transfusion recipients to receive either only male or only female donor transfusions.
Primary objective:
To confirm that a transfusion strategy of receiving male donor RBC (Red Blood Cell) units only will improve survival compared to a transfusion strategy of female donor RBC units in all hospital patients requiring a transfusion.
Secondary objectives:
- To assess effects of male RBC units on major morbidities (cancer, infection, end-organ damage)
- To assess effects across major patient subgroups (major surgery, intensive care, oncology)
- To assess the effect of female donor pregnancy history on recipient transfusion outcome
- To build capacity to conduct large innovative prospective pragmatic clinical trials in transfusion medicine using routinely collected clinical and administrative information.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 28 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients (excluding neonates) requiring one or more allogeneic RBC transfusions for the treatment of anemia will be included.
排除标准
- •Patients that do not have a valid Ontario Health Insurance Plan (OHIP) number at time of first transfusion
- •Patients that require emergent release of a RBC transfusion and in whom emergency randomization could not be completed
- •Patients with complex antibody profile in which it is impossible to match RBC units
结局指标
主要结局
Survival
时间窗: 2 years
Measured from date of first randomization to date of death or end of study 2 years from first patient enrollment.
次要结局
- Myocardial infarctions(2 years)
- Length of hospital stay(2 years)
- Survival(30 days, 3 months, 6 months and 1 year)
- Health system costs(2 years)
- New occurrence of hemodialysis(2 years)
- New ICU admission(2 years)
- Re-hospitalization(2 years)
- Occurrence of new cancer(2 years)
- Recurrence of cancer(2 years)
- Infection rates(2 years)