NCT03930459终止不适用
Clinical Trial to Compare the Efficacy of Ex-situ Normothermic Perfusion With Cold Storage in the Transplant With Steatotic Liver Graft.
Instituto de Investigacion Sanitaria La Fe1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2019年4月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Peak of transaminases (AST and ALT)
研究概览
简要总结
Prospective, randomized, controlled clinical trial to determine the overall efficacy of normothermic machine perfusion (NMP) for steatotic liver preservation versus traditional static cold storage (SCS), in 50 liver transplant recipients with 1-year follow-up.
详细描述
This is a prospective, randomized, controlled clinical trial comparing static cold storage (SCS) versus normothermic machine perfusion (NMP) for organ preservation before liver transplantation with steatotic livers (between 30 % and 60% of histologic macrovesicular steatosis), in order to:
Main Objective:
To compare the effect of NMP versus SCS in preventing preservation injury and graft dysfunction, as measured by highest transaminase levels during the first week after liver transplantation.
Secondary Objectives:
- To compare graft and patient survival between the NMP and SCS steatotic livers.
- To compare the liver biochemical function between the NMP and SCS steatotic livers.
- To compare the physiological response to the reperfusion between the NMP and SCS steatotic livers.
- To compare the evidence of reperfusion injury between the NMP and SCS steatotic livers.
- To compare the evidence of ischemic cholangiopathy between the NMP and SCS steatotic livers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •LIVER DONOR:
- •Donors older than 16 years
- •Liver donation grafts due to brain death
- •Steatosis confirmed by histological study (between 30% and 60% of macrovesicular steatosis)
- •LIVER RECIPIENT:
- •Adult patients (18 years or older)
- •Active liver transplant waiting list candidate
- •Able to give informed consent
排除标准
- •LIVER DONOR:
- •Living donors
- •Liver destined to the transplant "split"
- •Donor age <16 years
- •Donation after death due to asystole.
- •When the biopsy establishes a steatosis ≥ 50%, patients who fulfill at least 3 of the following 5 risk factors will be excluded: Transaminases (AST and ALT) ≥ 200 U / L; Age ≥ 55 years; Hypernatremia ≥ 155 mEq / L; Cardiovascular risk factors, at least 2 of the following 5: DM, HTA, IMC ≥ 35, Active smoking, ischemic stroke; Days of stay in ICU ≥ 4 days with vasoactive drugs (noradrenaline or dobutamine at any dose)
- •LIVER RECIPIENT:
- •Age under 18
- •Acute/fulminant hepatic failure
- •Transplant of more than one organ (for example, liver and kidney)
- •Rejection of informed consent
- •Unable to give informed consent
结局指标
主要结局
Peak of transaminases (AST and ALT)
时间窗: Day 5 post-transplant.
Peak of transaminases (AST and ALT) l
时间窗: Day 7 post-transplant.
次要结局
- Renal replacement therapy need(Day 30, month 6, month 12 post- transplant)
- Intraoperative thromboelastogram result(In transplant surgery)
- Biochemical function of the liver measured by INR post-transplant levels(Day 1, day 3, day 5, day 7, day 30, month 6, month 12 post- transplant)
- Biochemical function of the liver measured by GGT post-transplant levels(Day 1, day 3, day 5, day 7, day 30, month 6, month 12 post- transplant)
- Graft survival(Day 30 post-transplant, month 6 post-transplant, month 12 post-transplant.)
- Early graft dysfunction(7 days post-transplant)
- Intensive care stay duration(Day 30)
- Primary graft failure(Day 10 post-transplant.)
- Patient survival(Day 30 post-transplant, month 6 post-transplant, month 12 post-transplant.)
- Post-reperfusion syndrome, measured by mean arterial pressure (MAP) levels(During the first 5 minutes after reperfusion)
- Biochemical function of the liver measured by ALT post-transplant levels(Day 1, day 3, day 5, day 7, day 30, month 6, month 12 post- transplant)
- Hospital stay duration(Day 30)
- Biochemical function of the liver measured by AST post-transplant levels(Day 1, day 3, day 5, day 7, day 30, month 6, month 12 post- transplant)
- Biochemical function of the liver measured by Bilirubin post-transplant levels(Day 1, day 3, day 5, day 7, day 30, month 6, month 12 post- transplant)
- Histological evidence of reperfusion injury(In transplant surgery)
- Evidence of biliary stenosis in magnetic resonance cholangiography (MRS).(6 months after transplantation.)
研究者
研究点 (1)
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