跳至主要内容
临床试验/NCT06230198
NCT06230198招募中不适用

The Effect of Retrograde Autologous Priming on Transfusion Requirements After Cardiac Surgery (TheRAPy): a Multiple Period Vanguard Cluster Crossover Trial

Population Health Research Institute8 个研究点 分布在 1 个国家目标入组 4,500 人开始时间: 2024年12月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
4,500
试验地点
8
主要终点
Feasibility of implementing a full-scale randomized cluster crossover trial

研究概览

简要总结

The TheRAPy vanguard trial is a multicentre, multiple period randomized, cluster crossover vanguard trial testing the feasibility of a full-scale trial to evaluate whether a centre-based policy of routine use of RAP versus a policy of crystalloid priming reduces RBC transfusion for patients undergoing cardiac surgery on cardiopulmonary bypass. It will also provide information about key parameters of the TheRAPy full-scale trial.

详细描述

About 50% of patients undergoing cardiac surgery require red blood cell (RBC) transfusion. Given the limited blood supply and harms of transfusion, evidence-based blood conservation strategies are a priority. There is one such simple conservation technique called Retrograde autologous priming (RAP), in which the patient's own blood, rather than crystalloid fluid, is used to prime the heart-lung machine. Ultimately, it minimizes the loss of RBCs during surgery. Despite evidence of RAP reducing incidence of RBC transfusions by 40% and RBC units transfused by 38% in small randomized trials, it is not routinely used due to the uncertainty about overall benefit and potential harms. Routine RAP may be beneficial, but this needs to be confirmed in a large pragmatic randomized trial. Therefore, the goal of this vanguard trial is to assess the feasibility of a full-scale multi-centre randomized cluster crossover trial to determine whether an institutional policy of routine RAP reduces the number of RBC units transfused up to 72 hours after cardiac surgery compared to crystalloid priming. This will include 4 sites that will test the two policies in an alternating sequence during 12 periods of 4 weeks, with an expected volume of 4500 cardiac surgery patients. If the adherence to both polices is >=90%, a full trial will be conducted. The findings of this study have the potential to improve the outcomes of tens of thousands of patients around the world and will provide the basis for cardiac practice guidelines.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
10 Years 至 110 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospitals completing >200 adult cardiac surgical cases a year; (ii) 95% of cardiovascular surgery group (i.e., cardiac anesthesiologists, surgeons, and perfusionists) agree to manage patients under both autologous priming policies as per their randomization schedule for the duration of the trial.
  • All patients undergoing cardiac surgery on cardiopulmonary bypass at an enrolled site during the trial period will be included in data collection.

排除标准

  • Complete <=200 cardiac surgical cases.
  • <95% of their cardiovascular surgery group agrees to manage patients according to either of the two policies.

结局指标

主要结局

Feasibility of implementing a full-scale randomized cluster crossover trial

时间窗: 6 months

Feasibility is defined as adherence \>90% to both institutional policies applied in random sequence.

次要结局

  • Data Collection about Critical Parameters(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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