Protocol of a randomised controlled, open-label trial of ex vivo normothermic perfusion versus static cold storage in donation after circulatory death renal transplantation.
Protocol of a randomised controlled, open-label trial of ex vivo normothermic perfusion versus static cold storage in donation after circulatory death renal transplantation.
复制标题
循环死亡肾移植后捐赠中捐赠中的随机对照，开放标签试验的随机对照，开放标签试验。
DOI：
10.1136/bmjopen-2016-012237
复制
发表时间：
2017-01-23
期刊：
影响因子：
2.9
通讯作者：
Nicholson ML
中科院分区：
文献类型：
--
作者：
Hosgood SA;Saeb-Parsy K;Wilson C;Callaghan C;Collett D;Nicholson ML
离体常温灌注（EVNP）是一种在移植前修复肾脏并恢复肾功能的新技术。来自一系列EVNP在扩展标准供体肾中的I期数据已经确立了该技术在临床实践中的安全性和可行性。这是一项基于英国的II期多中心随机对照试验，旨在评估EVNP与传统静态冷藏技术相比在循环死亡（DCD）肾移植后捐献中的疗效。本研究将招募400例接受DCD供体肾脏（III类和IV类，对照）的患者。到达移植中心后，肾脏将随机接受EVNP（n=200）或保持静态冷藏（n=200）。接受EVNP的肾脏将在移植前在接近体温下用氧合浓缩红细胞溶液灌注60分钟。 主要结局指标将由移植后第一周内移植物功能延迟恢复（DGF）的发生率确定，DGF定义为需要透析。次要结果测量包括原发性无功能的发生率、DGF的持续时间、功能性DGF（定义为移植后第一周连续3天血清肌酐下降<10%）、第2天和第5天的肌酐降低率、住院时间、活检证实的急性排斥反应率、移植后1、3、6和12个月的血清肌酐和估计的肾小球滤过率以及患者和同种异体移植物存活率。 将记录EVNP评估评分，还将使用组织、血液和尿液样本测量纤维化和炎症水平。道德和传播。该研究已获得国家卫生服务（NHS）健康研究机构研究伦理委员会的批准。研究结果预计将于2020年公布。ISRCTN 15821205;预结果。
Ex vivo normothermic perfusion (EVNP) is a novel technique that reconditions the kidney and restores renal function prior to transplantation. Phase I data from a series of EVNP in extended criteria donor kidneys have established the safety and feasibility of the technique in clinical practice. This is a UK-based phase II multicentre randomised controlled trial to assess the efficacy of EVNP compared with the conventional static cold storage technique in donation after circulatory death (DCD) kidney transplantation. 400 patients receiving a kidney from a DCD donor (categories III and IV, controlled) will be recruited into the study. On arrival at the transplant centre, kidneys will be randomised to receive either EVNP (n=200) or remain in static cold storage (n=200). Kidneys undergoing EVNP will be perfused with an oxygenated packed red cell solution at near body temperature for 60 min prior to transplantation. The primary outcome measure will be determined by rates of delayed graft function (DGF) defined as the need for dialysis in the first week post-transplant. Secondary outcome measures include incidences of primary non-function, the duration of DGF, functional DGF defined as <10% fall in serum creatinine for 3 consecutive days in the first week post-transplant, creatinine reduction ratio days 2 and 5, length of hospital stay, rates of biopsy-proven acute rejection, serum creatinine and estimated glomerular filtration rate at 1, 3, 6 and 12 months post-transplant and patient and allograft survival. The EVNP assessment score will be recorded and the level of fibrosis and inflammation will also be measured using tissue, blood and urine samples. Ethics and dissemination. The study has been approved by the National Health Service (NHS) Health Research Authority Research Ethics Committee. The results are expected to be published in 2020. ISRCTN15821205; Pre-results.