Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Early allograft dysfunction
研究概览
简要总结
The goal of this clinical trial is to assess the ability of Normothermic Machine Perfusion (NMP) to resuscitate moderately steatotic livers for transplantation in patients. This will be a single-site clinical trial placing donor livers with 30-60% macrosteatosis on NMP, and then transplanting those that meet commonly accepted viability criteria. The results of this study could lead to a trial extending NMP transplantation to severely steatotic livers, further expanding the donor organ pool.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Listed for liver transplantation at MGH
- •Calculated MELD-Na score <= 25
- •Able to consent
排除标准
- •Status 1a
- •Cardiac or pulmonary disease
- •Prior liver transplant
- •Requiring pressors at the time of liver offer
- •MELD<15 and asymptomatic from liver disease
结局指标
主要结局
Early allograft dysfunction
时间窗: First week after transplant
Number of participants with initial poor function of liver allograft: measured by presence of 1 or more of the following: aspartate aminotransferase (AST) level higher than 2000 IU/L (to convert to microkatals per liter, multiply by 0.0167) within the first 7 postoperative days; bilirubin 10 mg/dL or higher (to convert to micromoles per liter, multiply by 17.104) on postoperative day 7; international normalized ratio (INR) of 1.6 or higher on postoperative day 7; or graft primary nonfunction within the first 7 days, defined as irreversible graft dysfunction leading to recipient death or emergency retransplant, in the absence of immunologic or surgical causes
次要结局
- Intraoperative inotropic support(At reperfusion, 15 minutes, 1 hour, 2 hours, and 3 hours after reperfusion)
- Need for post-operative inotropic support(First 30 days post-transplantation)
- ICU length of stay(First 30 days post-transplantation)
- Renal replacement therapy requirement(First 30 days post-transplantation)
- Total bilirubin(First 7 days post-transplantation or within first 30 days post-op if discharge is longer than 7 days out)
- Length of post-operative mechanical ventilation(First 30 days post-transplantation)
- Additional procedures(Assessed at 3, 6, and 12 months post-transplant)
- Internal Normalized Ratio (INR)(First 7 days post-transplantation or within first 30 days post-op if discharge is longer than 7 days out)
- 30-day patient survival(First 30 days post-transplantation)
- Adverse events(First 30 days post-transplantation)
- Re-admissions(Assessed at 3, 6, and 12 months post-transplant)
- Presence of steatosis by imaging or histology(Assessed at 3, 6, and 12 months post-transplant)
- Renal dysfunction(Assessed at 3, 6, and 12 months post-transplant)
- Immunosuppression medications(Assessed at 3, 6, and 12 months post-transplant)
- Dosage of immunosuppression medications(Assessed at 3, 6, and 12 months post-transplant)
- Patient death(Assessed at 3, 6, and 12 months post-transplant)
- Length of post-operative inotropic support(First 30 days post-transplantation)
- Biopsy-proven rejection episodes(Assessed at 3, 6, and 12 months post-transplant)
- Liver function tests more than 3 times normal(Assessed at 3, 6, and 12 months post-transplant)
- Need for post-operative mechanical ventilation(First 30 days post-transplantation)
- Peak AST and ALT(First 7 days post-transplantation)
- Re-listing for transplantation(Assessed at 3, 6, and 12 months post-transplant)
- Degree of steatosis by imaging or histology(Assessed at 3, 6, and 12 months post-transplant)
- Hyperlipidemia(Assessed at 3, 6, and 12 months post-transplant)
- Graft failure(Assessed at 3, 6, and 12 months post-transplant)
- Ischemic cholangiopathy and anastomotic strictures by imaging(Assessed at 3, 6, and 12 months post-transplant)
- Vascular complications by cross-sectional imaging or angiography(Assessed at 3, 6, and 12 months post-transplant)
- Drug levels of immunosuppression medications(Assessed at 3, 6, and 12 months post-transplant)
研究者
Heidi Yeh
Principal Investigator
Massachusetts General Hospital