The Effect of Remote Ischemic Preconditioning on Ischemia/Reperfusion Injury in a Liver Transplant Recipient (TRSPLNT) - A Randomized, Controlled, Double-blinded Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Post-operative change in ALT
研究概览
简要总结
Ischemia and reperfusion injury is unavoidable during a liver transplantation. Remote ischemic preconditioning, a safe and feasible method, has previously been shown to reduce ischemia and reperfusion injury. In the transplantation setting, focus of remote ischemic preconditioning has been on the donor. However, preconditioning of the recipient may be a better approach due to the mechanisms by which ischemic preconditioning protects against ischemia and reperfusion injury.
The aim of this randomised, double-blinded clinical trial is to biochemically assess the liver function after application of remote ischemic preconditioning on the recipient.
详细描述
Background The use of solid organ transplantation, including liver transplantation, is the golden standard for many end-stage solid organ diseases. Ischemia and reperfusion injury is unavoidable during a liver transplantation. Remote ischemic preconditioning, a safe and feasible method, has previously been shown to reduce ischemia and reperfusion injury. This may have a similar effect in a liver transplantation setting. In the transplantation setting, focus of remote ischemic preconditioning has been on the donor. However, preconditioning of the recipient may be a better approach due to the mechanisms by which ischemic preconditioning protects against ischemia and reperfusion injury.
The aim of this randomised, double-blinded clinical trial is to biochemically assess the liver function after application of remote ischemic preconditioning on the recipient.
Methods 52 patients undergoing a liver transplantation, included in accordance to the inclusion criteria, will be allocated to an intervention group (rIC-group) and compared to a retrospective non-intervention control group (non-rIC group) consisting of 52 patients. Patients in the non-intervention group will also be included in accordance to the inclusion criteria. Within two hours before surgery, patients in the intervention group will be subjected to four rounds of five-minute inflations and five-minute deflations of a pneumatic tourniquet applied on the right leg.
Follow-up time will be 30 days.
Measurements The aim of this trial is to assess the effect of remote ischemic preconditioning on the extent of liver injury and inflammation as a result of ischemia and reperfusion injury. Assessment will be done by measurement of biomarkers relevant to liver function and liver injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The patient enrolment will be done by the on-call doctor and intervention will be performed by unblinded research personnel who won't be involved in sample collection or data analysis.
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
- •Patients undergoing liver transplantation
- •Patients aged 18 or above
- •Patients who have given an informed consent
排除标准
- •Patients undergoing re-transplantation.
- •Patients who do not or cannot give an informed consent.
- •Patients who have undergone surgery six weeks prior to liver transplantation.
- •Patients with known peripheral vascular disease.
- •Patients with an infection localized to the area of rIC-intervention
- •Patients with at a high risk or with previous history of multiple thrombo-embolic diseases.
- •Patients undergoing active immunosuppressive therapy
结局指标
主要结局
Post-operative change in ALT
时间窗: Day 0-4
Extent of liver injury measured as change in ALT postoperative from day zero to day four .
次要结局
- Post-operative change in Bilirubin(Day 0-4)
- Post-operative change in Aspartate Amonitransferase(Day 0-4)
- Post-operative change in Alkaline Phosphatase(Day 0-4)
- Post-operative change in International Normalised Ratio(Day 0-4)
研究者
Waqas Farooqui
MD, Principal Investigator
Rigshospitalet, Denmark