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首页> 外文期刊>Transplantation Research >Protocol TOP-Study (tacrolimus organ perfusion): a prospective randomized multicenter trial to reduce ischemia reperfusion injury in transplantation of marginal liver grafts with an ex vivo tacrolimus perfusion
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Protocol TOP-Study (tacrolimus organ perfusion): a prospective randomized multicenter trial to reduce ischemia reperfusion injury in transplantation of marginal liver grafts with an ex vivo tacrolimus perfusion

机译：方案TOP-研究（他克莫司器官灌注）：一项前瞻性随机多中心试验，以减少体外他克莫司灌注对边缘性肝移植的缺血再灌注损伤

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Background Critical organ shortage results in the utilization of extended donor criteria (EDC) liver grafts. These marginal liver grafts are prone to increased ischemia reperfusion injury (IRI) which may contribute to deteriorated graft function and survival. Experimental data have shown that the calcineurin inhibitor tacrolimus exerts protective effects on hepatic IRI when applied intravenously or directly as a hepatic rinse. Therefore, the aim of the present study is to examine the effects of an ex vivo tacrolimus perfusion on IRI in transplantation of EDC liver grafts. Methods/Design The TOP-Study (tacrolimus organ perfusion) is a randomized multicenter trial comparing the ex vivo tacrolimus perfusion of marginal liver grafts with placebo. We hypothesize that a tacrolimus rinse reduces IRI, potentially improving organ survival following transplantation of EDC livers. The study includes livers with two or more EDC, according to Eurotransplant International Foundation’s definition of EDC livers. Prior to implantation, livers randomized to the treatment group are rinsed with tacrolimus at a concentration of 20?ng/ml in 1000?ml Custodiol solution and in the placebo group with Custodiol alone. The primary endpoint is the maximum serum alanine transamninase (ALT) level within the first 48?hours after surgery; however, the study design also includes a 1-year observation period following transplantation. The TOP-Study is an investigator-initiated trial sponsored by the University of Munich Hospital. Seven other German transplant centers are participating (Berlin, Frankfurt, Heidelberg, Mainz, Münster, Regensburg, Tübingen) and aim to include a total of 86 patients. Discussion Tacrolimus organ perfusion represents a promising strategy to reduce hepatic IRI following the transplantation of marginal liver grafts. This treatment may help to improve the function of EDC grafts and therefore safely expand the donor pool in light of critical organ shortage. Trial register EudraCT number: 2010-021333-31, ClinicalTrials.gov identifier: NCT01564095
机译：背景关键器官短缺导致使用扩展供体标准（EDC）肝移植物。这些边缘肝移植物易于增加缺血再灌注损伤（IRI），这可能导致移植物功能和存活率下降。实验数据表明，钙调神经磷酸酶抑制剂他克莫司在静脉内或直接作为肝冲洗液使用时对肝IRI发挥保护作用。因此，本研究的目的是检查在体外EDC肝移植中他克莫司灌流对IRI的影响。方法/设计TOP-研究（他克莫司器官灌注）是一项随机的多中心试验，比较了边缘肝移植物与安慰剂的离体他克莫司灌注。我们假设他克莫司冲洗可减少IRI，潜在地改善EDC肝移植后的器官存活率。根据欧洲移植国际基金会（Eurotransplant International Foundation）对EDC肝脏的定义，该研究包括具有两个或多个EDC的肝脏。植入前，将随机分配至治疗组的肝脏用他克莫司在1000？ml的Custodiol溶液中冲洗，浓度为20？ng / ml，而在安慰剂组中，仅使用Custodiol冲洗。主要终点是手术后48小时内的最高血清丙氨酸转氨酶（ALT）水平。但是，研究设计还包括移植后的1年观察期。 TOP-研究是由慕尼黑大学医院赞助的研究者发起的试验。其他七个德国移植中心（柏林，法兰克福，海德堡，美因茨，明斯特，雷根斯堡，蒂宾根）也参加了该研究，目的是使总共86名患者参加。讨论他克莫司器官灌注代表减少边缘肝移植物移植后降低肝脏IRI的一种有前途的策略。这种治疗可能有助于改善EDC移植物的功能，因此可以根据关键器官短缺情况安全地扩大供体库。试验注册EudraCT号：2010-021333-31，ClinicalTrials.gov标识符：NCT01564095

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