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临床试验/NCT01211366
NCT01211366已完成不适用

Post-operative Infusion of Intra-operative Cell Salvage Reduces Allogeneic Blood Product Transfusions and Volume Resuscitation in Pediatric Cardiac Surgery and Improves Clinical Outcomes

University of Rochester2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2010年10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
106
试验地点
2
主要终点
Comparison of volume of allogeneic blood products and crystalloid/colloid infusions between groups

研究概览

简要总结

Transfusion of washed intra-operative cell salvage post-operatively in the PCICU can be performed safely without increased risk of bleeding or release of inflammatory mediators. This will reduce the need for allogeneic blood products as well as crystalloid and colloid infusions and thus decrease the length of ventilation and intensive care duration for these infants.

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Weight < or = 20Kg;
  • Cardiac surgery with CPB at URMC;
  • informed consent

排除标准

  • weight > 21 Kg;
  • inability to obtain consent;
  • non-English speaking

结局指标

主要结局

Comparison of volume of allogeneic blood products and crystalloid/colloid infusions between groups

时间窗: 2 years

To compare the volume of allogeneic blood products and crystalloid/colloid infusions between patients randomized to receive washed intra-operative cell salvage vs our current standard for volume replacement for the first 24 hours post-op

次要结局

  • comparison of bleeding, use of coagulant products, and inflammatory markers between groups(2 years)
  • comparison of clinical outcomes between groups(2 years)

研究者

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

jill cholette

Assistant Professor of Pediatrics

University of Rochester

研究点 (2)

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