NCT00235183已完成4 期
Plasma Transfusion in Liver Transplantation : a Randomized, Double Blind, Multicenter Trial of Methylene Blue, Solvent/Detergent and Quarantined Plasma.
Etablissement Français du Sang1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2005年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Volume of transfused plasma during surgery
研究概览
简要总结
The aim of the study is to compare the clinical efficacy of three types of plasma secured on the viral level either by quarantine or by chemical treatment in patients undergoing liver transplantation.
详细描述
Three types of plasma are transfused in bleeding patients undergoing liver transplantation:
- quarantined plasma,
- methylene blue treated plasma,
- solvent/detergent plasma. The main purpose is to show that the volume of methylene blue treated plasma consumed intraoperatively is equivalent to that of the 2 other types of plasma.
In addition, the correction of coagulation abnormalities are studied.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 yo and above
- •consent is signed,
- •liver transplantation is indicated,
- •plasma is transfused
排除标准
- •multiorgan transplantation (except combined kidney and liver transplantation)
- •allergy to methylene blue.
研究组 & 干预措施
Quarantined FFP
Active Comparator
Quarantined FFP
干预措施: plasma (Other)
Methylene blue FFP
Active Comparator
Methylene blue FFP
干预措施: plasma (Other)
Solvent detergent FFP
Active Comparator
Solvent detergent FFP
干预措施: plasma (Other)
结局指标
主要结局
Volume of transfused plasma during surgery
时间窗: 5 years
次要结局
- correction of coagulation abnormalities(5 years)
- immediate and delayed adverse events(15 days)
研究者
研究点 (1)
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