2024-518174-13-00招募中3 期
A Prospective, randomized, single blind, multicenter Phase III study on organ preservation with Custodiol-N solution compared with Custodiol solution in liver transplantation
Dr. Franz Koehler Chemie GmbH7 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年10月24日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Area under the curve (AUC) GPT (ALT) after transplantation during 7 days: with each liver transplant patient enrolled in the study, GPT will be measured once per day during the first 7 days, according to the standard practice of the center laboratory. Area under the curve will be analysed for this variable comparing Custodiol and Custodiol-N groups
研究概览
简要总结
To evaluate the area under the curve (AUC) GPT (ALT) after transplantation during 7 days
研究设计
- 分配方式
- Randomized
- 主要目的
- Custodiol-N / Custodiol
- 盲法
- Single (Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Recipients awaiting their first transplant
- •Recipients ≥18 years
- •Recipient's signed informed consent of data use and protection before the transplantation
- •Full organ transplantation
排除标准
- •Pregnant or lactating patients
- •Recipients participating in any interventional study (e.g. another study involving compound/interventions aimed at the reduction of preservation and/or ischemia/reperfusion injury)
- •All combined transplantations other than pancreas and kidney
- •High urgency patients
- •Patients in need of a retransplant
结局指标
主要结局
Area under the curve (AUC) GPT (ALT) after transplantation during 7 days: with each liver transplant patient enrolled in the study, GPT will be measured once per day during the first 7 days, according to the standard practice of the center laboratory. Area under the curve will be analysed for this variable comparing Custodiol and Custodiol-N groups
Area under the curve (AUC) GPT (ALT) after transplantation during 7 days: with each liver transplant patient enrolled in the study, GPT will be measured once per day during the first 7 days, according to the standard practice of the center laboratory. Area under the curve will be analysed for this variable comparing Custodiol and Custodiol-N groups
次要结局
- Absolute peak LDH within 7 days after transplantation: the highest peak of lactate-dehydrogenase within 7 days after transplantation according to the practice of the site laboratory
- Olthoff criteria: bilirubin, international normalized ratio of prothrombin (INR). The Olthoff criteria will be applied to evaluate initial poor function when one or more of the following parameters would be present: Bilirubin ≥ 10 mg/dl on Day 7 after the surgery; INR ≥ 1.6 on Day 7 after the surgery; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2000 IU/L within the first 7 days after the surgery
- MEAF score (Model for early allograft dysfunction)
- Evaluation of the moment (day) of peak GPT and peak LDH: the highest daily peak GPT and peak LDH will be evaluated for comparisons between groups
- Evaluation of the serum bilirubin, GOT, GPT, LDH, total albumin and PT at 3 months and 6 months: these parameters will be measured at 3 months and 6 months after liver transplantation according to the references values of the site laboratory
- Number of episodes of cholestasis
- Therapy for cholangitis
- Episodes of biliary leakage and intrahepatic and/or extrahepatic biliary strictures
- Comparison in Extended Criteria Donors: the influence of Custodiol-N in liver transplants with ECD and DCD donors will be compared. ECD donors are defined as high risk donors with a donor risk index (DRI) higher than 1.7
- Comparison in DCD donors: DCD donors are defined as donation after circulatory death donors and will be compared in liver transplants with Custodiol and Custodiol-N
研究者
Roman Petrov
Scientific
Dr. Franz Koehler Chemie GmbH
研究点 (7)
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