Continued Access Protocol To Evaluate the Effectiveness of the Portable Organ Care System (OCS) Liver for Preserving and Assessing Donor Livers for Transplantation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- TransMedics
- 入组人数
- 74
- 试验地点
- 33
- 主要终点
- Participants With Early Liver Allograft Dysfunction (EAD)
研究概览
简要总结
Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.
详细描述
A prospective, single arm, continued access protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers having one or more of the following characteristics:
- Donor age equal to or greater than 40 years old, or
- Expected cross clamp time of 6 hours or greater, or
- Donor after circulatory death (DCD) with age less than or equal to 55 years; or
- Steatotic lever >0% and less than or equal to 40% at time of retrieval, based on pre-retrieval histology)
A maximum of 21 sites will enroll up to 184 transplanted liver recipients. The primary effectiveness endpoint will be the incidence of Early Allograft Dysfunction (EAD) or primary non-function.
All recipients will be followed for 24 months from the date of transplantation (some of which will be post-market).
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
- •Registered primary liver transplant candidate, male or female
- •Age ≥ 18 years
- •Signed (1) written informed consent document and (2) authorization to use and disclose protected health information
排除标准
- •Acute, fulminant liver failure
- •Prior solid organ or bone marrow transplant
- •Chronic use of hemodialysis or diagnosis of chronic renal failure, defined as chronic serum creatinine of > 3 mg/dl for > 2 weeks and/or requiring hemodialysis
- •Multi-organ transplant
- •Ventilator dependent
- •Dependent on > 1 IV inotrope to maintain hemodynamics
- •Donor Inclusion Criteria
- •Donor age ≥ 40 years, or
- •Expected cross-clamp time ≥ 6 hours, or
- •Donor after circulatory death (DCD) with age ≤ 55 years, or
- •Steatotic liver > 0% and ≤ 40% macrosteatosis at time of retrieval
- •Donor Exclusion Criteria
- •Living donors
- •Liver intended for split transplants
- •Positive serology (HIV, Hepatitis B surface antigen & Hepatitis C)
- •Presence of moderate or severe traumatic liver injury, or anatomical liver abnormalities that would compromise ex-vivo perfusion of the donor liver (i.e., accessory blood vessels or other anatomy that require surgical repair) and livers with active bleeding (e.g., hematomas)
- •Donor livers with macrosteatosis of > 40% based on retrieval biopsy readout.
结局指标
主要结局
Participants With Early Liver Allograft Dysfunction (EAD)
时间窗: 7 days
Participants with Early liver Allograft Dysfunction (EAD) or primary non-function, defined as presence of one or more of the following criteria: AST level \> 2000 IU/ml within the first 7 postoperative days; Bilirubin ≥ 10 mg/dl on postoperative day 7; INR ≥ 1.6 on postoperative day 7; or Primary non-functioning graft within the first 7 days (defined as irreversible graft dysfunction requiring emergency liver re-transplantation or death, in the absence of immunologic or surgical causes)
次要结局
- Patient Survival at Day 30 After Transplant(30 days after transplant)