跳至主要内容
临床试验/NCT01173822
NCT01173822已完成不适用

Processed Residual Pump Blood in Cardiac Surgery: The PRBC Trial

Hamilton Health Sciences Corporation2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2004年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
the proportion of patients transfused with homologous red blood cells (RBC)

研究概览

简要总结

The study is an randomized controlled trial (RCT) of 198 coronary artery bypass graft (CABG) patients, exploring whether ultrafiltration of residual blood in the cardiopulmonary bypass circuit reduces transfusion and bleeding.

详细描述

Blood products are a limited resource and cardiac surgery is a high consumer. Processing residual cardiopulmonary bypass (CPB) volume via ultrafiltration may improve hemostasis and reduce transfusion through clearing activated complement, activated coagulation components, and proinflammatory cytokines. Unlike cell saver technology, ultrafiltration has the advantage of maintaining plasma proteins, platelets, and coagulation factors. We sought to establish if the processing of residual CPB volume with ultrafiltration reduces homologous blood transfusion and bleeding.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least 18 years of age
  • were to undergo isolated on-pump CABG
  • were able to give informed consent

排除标准

  • performed autologous blood donation
  • underwent off-pump CABG
  • emergency procedure
  • resternotomy
  • known bleeding disorder not drug related
  • history of heparin-induced thrombocytopenia
  • Jehovah's Witness
  • intra-operative catastrophe prior to randomization

结局指标

主要结局

the proportion of patients transfused with homologous red blood cells (RBC)

时间窗: At 30 days post-operatively

次要结局

  • Proportion of patients transfused with any blood product(At 30 days post-operatively)
  • Volume of pRBC's transfused post-operative(At 30 days post-operatively)
  • Post-operative hemorrhage(At 24 hours post-operative)
  • Discharge Hemoglobin(A date of discharge, median 5 days in study)
  • Length of hospital stay(From day to surgery to discharge, median 5 days in this study)

研究者

申办方类型
Other

研究点 (2)

Loading locations...

相似试验