Pilot Study to Assess Safety and Feasibility of Normothermic Machine Perfusion to Preserve and Evaluate Orphan Livers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The rate of primary non-function
研究概览
简要总结
Orphan livers are organs that have been declined for clinical use by all centers due to their marginality. The current standard of care of liver preservation before transplant is cold storage. NMP may allow these livers to be evaluated before transplantation. NMP has already been used in a clinical setting with promising results. The advantage to utilizing NMP is that it would attenuate the incidence and clinical impact of classical preservation injury, allow liver function assessment before implantation and thus improve donor pool and outcomes for high risk ECD liver transplants performed at our center.
详细描述
This will be a single center prospective cohort pilot study. 30 livers that have been declined for clinical use by all centers due to their marginality will be preserved with NMP in 1-18 hours after cross clamp and cold flush. The liver grafts at NMP will be at Physiological temperature and have oxygen and nutrient supply with continuous perfusion. Once the liver grafts have been evaluated and determined to be transplantable, the transplantation and post-transplant care will follow the standard of care. The follow-up period is 12 months after transplantation. The primary end point will be the rate of patient survival and primary non function (PNF) within 30 days after transplantation, while the secondary end points will be: Early Allograft Dysfunction (EAD), 6 months patient and graft survival, peak liver function tests in the first 7 days after transplantation, surgical outcomes (operative time, transfusion requirement etc.), rate of post-transplant kidney failure, assessment of histological ischemia reperfusion (liver and bile duct), rate of vascular complications, rate of biliary complications, hospital and ICU length of stay, rejection rate, infection rate, the ability to predict function based on "on-pump" viability markers, and the incidence of adverse effect (AE).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing primary liver transplantation
- •Age 18-75 years at the time of transplantation
- •Willingness and ability to comply with the study procedures
- •Signed Informed Consent Form
- •For patients with hepatocellular carcinoma as indication for Orthoptic Liver Transplantation (OLT), tumor must be within Milan Criteria or down-staged to Milan Criteria.
排除标准
- •Recipient Exclusion Criteria:
- •History of prior solid organ transplantation
- •Patient on a respiratory and/or cardiocirculatory support at the time of transplant
- •MELD score >35
- •HIV positive patient
- •Patient with current severe systemic infection
- •Multiorgan transplant
研究组 & 干预措施
Normothermic Liver perfusion
This group has the liver grafts preserved using the Normothermic Liver perfusion Device
干预措施: Normothermic Liver perfusion (Device)
结局指标
主要结局
The rate of primary non-function
时间窗: 30 days post-transplantation
primary non-function is defined as non life sustaining liver function requiring retransplantation or leading to death with 30 days after transplantation
The rate of patient survival
时间窗: 30 days post-transplantation
次要结局
- The rate of Early Allograft Dysfunction post-transplantation(7 days post-transplantation)
- graft survival(6 months post-transplantation)
- peak aspartate aminotransferase (AST) in the first 7 days post-transplantation(in the first 7 days post-transplantation)
- peak Alanine Aminotransferase (ALT) in the first 7 days post-transplantation(in the first 7 days post-transplantation)
- peak bilirubin in the first 7 days post-transplantation(in the first 7 days post-transplantation)
研究者
Koji Hashimoto
Staff Physician
The Cleveland Clinic