A multicenter randomized controlled trial of HC-A Ⅱ solution in kidney preservation
10.3760/cma.j.issn.0254-1785.2012.08.008
- VernacularTitle:HC-AⅡ器官保存液保存供肾的多中心随机对照临床研究
- Author:
Wenyu ZHAO
;
Youhua ZHU
;
Li ZENG
;
Lulin MA
;
Xiaodong ZHANG
;
Jianhua AO
;
Bingyi SHI
;
Ye TIAN
;
Jianghua CHEN
;
Zhishui CHEN
;
Long LIU
- Publication Type:Journal Article
- Keywords:
Kidney transplantation;
Organ preservation;
Organ preservation solutions
- From:
Chinese Journal of Organ Transplantation
2012;33(8):474-476
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo evaluate the efficacy and safety of HC-A Ⅱsolution in kidney preservation.Methods A multicenter,randomized,double-blind and controlled clinical trial was conducted.Between Jan.2008 and Dec.2010,kidney recipients from 9 transplant centers were randomly divided into two groups.Grafts in each group were perfused and stored in HC-A Ⅱ or HTK solutions respectively.Results277 patients were included in the Full Analysis Set (FAS),137 of whom were inHC-A Ⅱgroup and 140inHTK group. Demographic andbaseline medical characteristics were similar between the two groups.262 patients were included in the Per Protocol Set (PPS),133 of whom were in HC-A Ⅱ group and129 in HTK group.The percentages of patients with a serum creatinine level that returned to normal within 28 days postoperation were 86.9％ in HC-A Ⅱ group and 85.0％ in HTK group respectively (P＞0.05 ).The results from PPS analysis were consistent with those from FAS analysis The incidence of test-related adverse events was 2.9％ in HC-AⅡ group and 0.7％ in HTK group respectively (P＞0.05).No test-related serious adverse events occurred throughout the study.ConclusionHC-A Ⅱ solution,the same as HTK solution,is safe and effective in kidney preservation.
