NCT05194306已完成不适用
Evaluation of the Safety and Performance of Perla® Preservation Solution for Donor Liver and Kidney for Transplantation
Advanced Life Solutions1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2021年12月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Graft Function Rate (Kidney & Liver)
研究概览
简要总结
Perla® is a Cold Preservation Solution, with purpose to wash out, preserve during transport liver and kidney grafts in optimal conditions from the donor to the recipient.
The purpose of the PERTRIAL clinical investigation is to demonstrate the Performance and Safety of Perla® Cold Preservation solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Donor kidney / liver suitable for preservation
- •Donor age equal or over 18 years old
- •Donor meets one of the following conditions:
- •Donor after brain death (DBD), standard and extended criteria (SCD & ECD)
- •Donor after circulatory death (DCD), cardiac arrest Maastricht classification III (awaiting cardiac arrest, controlled)
排除标准
- •Donor participating at the same time in another Clinical Investigation
- •Recipient eligibility criteria:
- •Inclusion Criteria:
- •Patient registered primary kidney or liver transplant candidate, male or female
- •Patient ages ≥ 18 years old
- •Patient who has signed written informed consent
- •Exclusion criteria:
- •Patient recipient will not be included if any of the following conditions exists:
- •Prior solid organ or bone marrow transplant
- •Multi-organ transplant
- •Contraindications to transplantation (Active infection, active malignancy, pregnant females, females intending to get pregnant, or not willing to use a secure contraceptive method)
- •Participation in another clinical trial
- •Patient unable to give consent
研究组 & 干预措施
Perla® Cold Preservation solution
Experimental
Perla® is a Cold Preservation Solution, with purpose to wash out, preserve during transport liver and kidney grafts in optimal conditions from the donor to the recipient.
干预措施: Perla® Cold Preservation solution (Drug)
结局指标
主要结局
Graft Function Rate (Kidney & Liver)
时间窗: 7 days post transplant
次要结局
- Duration of delayed graft function (Kidney)(within 30 days post-transplant)
- Peak level of serum AST (Liver)(within 7 days post-transplant)
- Graft survival (Kidney & Liver)(14 & 30 days post-transplant)
- Evaluation of patient anxiety (Kidney & Liver)(pre-transplant)
- Rate of functional delayed graft function (f-DGF) (Kidney)(within 7 days post-transplant)
- Daily serum creatinine (Kidney)(7 days post-transplant, or until the patient is discharged - whichever is earliest)
- Post-reperfusion syndrome (Liver)(during operative procedure)
- Rate of an event or serious adverse device effects (Kidney & Liver)(within 30 days post-transplant)
研究者
研究点 (1)
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