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临床试验/NCT02595385
NCT02595385Unknown不适用

Blood Conservation in Adult Cardiac Surgery, What is the Way Forward in Today's Practice?

Belfast Health and Social Care Trust1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2015年2月最近更新:
适应症

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;

  1. RAP alone
  2. Cell Salvage alone
  3. RAP plus cell salvage
  4. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alison Murphy

Research Administrator

Belfast Health and Social Care Trust

研究点 (1)

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