A Prospective, Randomized, Single Blind, Multicenter Phase III Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 9
- 主要终点
- Creatine kinase Myocard type "CK-MB" peak value
研究概览
简要总结
The objective of this investigation is to demonstrate non-inferiority in outcome of Custodiol-N against Custodiol in heart transplantation.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Donor criteria:
- •deceased donors should fulfil the criteria for organ donation (SCD) Patient criteria
- •recipients awaiting their first transplant
- •recipients ≥ 18 and >/= 65 years
- •recipient's signed informed consent
- •waiting list
排除标准
- •Donor criteria:
- •not applicable
- •Patient criteria:
- •recipients participating in another interventional study
- •pregnant or lactating patients
- •history/demonstration of HIV antibodies or AIDS
- •multiorgan transplantation
- •transMedics pump
- •the explantation team is affiliated another clinic than transplantation team
研究组 & 干预措施
Custodiol
comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation
干预措施: organ perfusion for heart transplantation (Procedure)
Custodiol-N
comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation
干预措施: Custodiol-N (Drug)
Custodiol-N
comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation
干预措施: organ perfusion for heart transplantation (Procedure)
Custodiol
comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation
干预措施: Custodiol (Drug)
结局指标
主要结局
Creatine kinase Myocard type "CK-MB" peak value
时间窗: from 4 to 168 hours after release of the aortic cross clamp
day 1: measurements 4, 8, 12, 16, 20, 24 hours ± 30 min; day 2-3: measurements 8, 16 and 24 hours ± 2 hours; day 4-7 one time/day
次要结局
- Catecholamine requirement(from entry to the trial up to day 7)
- Patient survival(at 7 days and 1, 3 and 12 months)
- Complications(from the time of the transplantation up to day 7)