Blood Conservation in Adult Cardiac Surgery, What is the Way Forward in Today's Practice?
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Number of units of packed red blood cells transfused
研究概览
简要总结
The aim of this study is to compare retrograde autologous priming (RAP) of the bypass circuit to cell salvage (CS) as part of blood conservation strategies in adult cardiac surgery. It hypothesizes that RAP is at least as effective as cell salvage in terms of blood conservation but at the same time more cost effective.
详细描述
Cardiac surgery is a major blood consumer. Current evidence shows there is no benefit from transfusion for haematocrits as low as 21% and the risk of death within 30 days of surgery is almost 6 times higher for patients who receive blood. In addition, transfused patients are more likely to experience increased infections and ischaemic complications like myocardial infarction, stroke and renal compromise. While it is agreed to avoid blood transfusion when feasible, there is no current consensus on the best strategy to maintain an acceptable haemocrit and minimise the need for allogenic blood transfusion. Two of the many strategies that have been employed are Retrograde Autologous Prime (RAP) of the bypass circuit and cell salvage (CS) with reinfusion of shed blood.
This study is a prospective, randomised controlled trial with 240 patients undergoing a single procedure adult cardiac surgery that will be randomised to either full crystalloid prime volume or RAP, with or without cell salvage. There will be four study arms;
- RAP alone
- Cell Salvage alone
- RAP plus cell salvage
- Control group
Results will follow analyse of the data using a logistic regression using a design matric with blood transfused as a key explanatory variable with scope to add in patient covariables. It is expected that date will be analysed after 100 patients and if significance is achieved then the study can be terminated.
The study will aim to identify those patients that receive a blood transfusion intra or post-operatively. Symptomatology from anaemia is subjective and hard to measure. The studies linking transfusion to cardiac surgery outcomes are retrospective; despite careful risk adjustment, it is possible that these associations reflect a tendency amongst clinicians to transfuse the most critically ill patients or miss another important confounder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Less than 80 years of age
- •Undergoing single procedure surgery
- •Be on single anti-platelet therapy
- •To have stopped warfarin pre-operatively with a INR of <1.5
- •Have stable coronary disease
- •Have good Left Ventricular function
排除标准
- •Redo procedures
- •Emergency Surgery
- •Be on dual antiplatelet therapy
- •Have pre-operative kidney dysfunction with eGFR <60ml/min
- •Have post-operative drainage >200ml per hour or require re-exploration for bleeding.
结局指标
主要结局
Number of units of packed red blood cells transfused
时间窗: through study completion, an average of 2 weeks
次要结局
- Adverse reaction to RAP measured by systolic BP <90mmHg during initiation of bypass.(intra-operatively)
研究者
Alison Murphy
Research Administrator
Belfast Health and Social Care Trust
