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临床试验/NCT00318227
NCT00318227已完成不适用

Evaluation of a Liberal Versus Restrictive Blood Transfusion Strategy in Elderly Patients Following Coronary Bypass or Aortic Valve Surgery

Lawson Health Research Institute2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2004年6月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
73
试验地点
2
主要终点
Distance walked during 6 minute walk test at 5 weeks postop

研究概览

简要总结

The purpose of this study is to determine whether a less restrictive strategy of red blood cell transfusion in elderly patients following coronary bypass surgery results in enhanced postoperative recovery as determined by quality of life assessment, exercise tolerance and clinical outcomes.

Two postoperative transfusion strategies:

  1. Liberal - transfused when Hgb is <100g/L
  2. Restrictive - transfused when Hgb is <70g/L

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
Single (Participant)

入排标准

年龄范围
70 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients >=70 years of age undergoing non-emergency coronary artery bypass surgery
  • Initial postoperative hemoglobin level 70-90g/L

排除标准

  • Patients who are unable to provide informed consent in English
  • Patients with preoperative hemoglobin concentrations <100g/L
  • Patients who require emergency re-operation
  • Patients with intraoperative or postoperative bleeding diathesis
  • Patients with postoperative clinical instability (eg. low output state)
  • Patients in whom insertion of an intra-aortic balloon pump is required

研究组 & 干预措施

Liberal Red cell transfusion arm

Active Comparator

Transfusion if Hgb <100g/L

干预措施: Blood Transfusion (Procedure)

Restrictive Red Cell transfusion

Active Comparator

Transfusion if Hgb <70g/L

干预措施: Blood Transfusion (Procedure)

结局指标

主要结局

Distance walked during 6 minute walk test at 5 weeks postop

时间窗: 5 weeks

次要结局

  • renal failure, hospital length of stay, Quality of Life questionnaire(during hospital stay)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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