Abstract：
BACKGROUND: M101 is an extracellular hemoglobin isolated from a marine lugworm and is present in the medical device HEMO2 life®. The clinical investigation OXYOP was a paired kidney analysis (n = 60) designed to evaluate the safety and performance of HEMO2 life® used as an additive to preservation solution in renal transplantation. The secondary efficacy endpoints showed less delayed graft function (DGF) and better renal function in the HEMO2 life® group but due to the study design cold ischemia time (CIT) was longer in the contralateral kidneys.
METHODS: An additional analysis was conducted including OXYOP patients and patients from the ASTRE database (n = 6584) to verify that the decrease in DGF rates observed in the HEMO2 life® group may not be due solely to the shorter CIT but also to HEMO2 life® performance. Kaplan-Meier estimate curves of cumulative probability of achieving a creatinine level below 250 µmol/L were generated and compared in both groups. A Cox model was used to test the effect of the explanatory variables (use of HEMO2 life® and CIT). Finally, a bootstrap strategy was used to randomly select smaller samples of patients and test them for statistical comparison in the ASTRE database.
RESULTS: Kaplan-Meier estimate curves confirmed the existence of a relation between DGF and CIT and Cox analysis showed a benefit in the HEMO2 life® group regardless of the associated CIT. Boostrap analysis confirmed these results.
CONCLUSIONS: The present study suggested that the better recovery of renal function observed among kidneys preserved with HEMO2 life® in the OXYOP study is a therapeutic benefit of this breakthrough innovative medical device.
METHODS: An additional analysis was conducted including OXYOP patients and patients from the ASTRE database (n = 6584) to verify that the decrease in DGF rates observed in the HEMO2 life® group may not be due solely to the shorter CIT but also to HEMO2 life® performance. Kaplan-Meier estimate curves of cumulative probability of achieving a creatinine level below 250 µmol/L were generated and compared in both groups. A Cox model was used to test the effect of the explanatory variables (use of HEMO2 life® and CIT). Finally, a bootstrap strategy was used to randomly select smaller samples of patients and test them for statistical comparison in the ASTRE database.
RESULTS: Kaplan-Meier estimate curves confirmed the existence of a relation between DGF and CIT and Cox analysis showed a benefit in the HEMO2 life® group regardless of the associated CIT. Boostrap analysis confirmed these results.
CONCLUSIONS: The present study suggested that the better recovery of renal function observed among kidneys preserved with HEMO2 life® in the OXYOP study is a therapeutic benefit of this breakthrough innovative medical device.
摘要：
背景：M101是从海洋狼虫中分离出的细胞外血红蛋白，存在于医疗设备HEMO2life®中。临床研究OXYOP是配对的肾脏分析（n=60），旨在评估HEMO2life®在肾移植中用作保存溶液添加剂的安全性和性能。次要疗效终点显示HEMO2life®组中延迟移植功能（DGF）较少，肾功能较好，但由于研究设计，对侧肾脏的冷缺血时间（CIT）更长。
方法：对OXYOP患者和ASTRE数据库中的患者（n=6584）进行了额外分析，以验证在HEMO2life®组中观察到的DGF率降低可能不仅是由于较短的CIT，而且还由于HEMO2life®表现。生成并比较两组肌酐水平低于250µmol/L的累积概率的Kaplan-Meier估计曲线。Cox模型用于测试解释变量的影响（使用HEMO2life®和CIT）。最后,使用引导策略随机选择较小的患者样本,并在ASTRE数据库中进行统计学比较.
结果：Kaplan-Meier估计曲线证实了DGF和CIT之间存在关系，而Cox分析显示，无论相关CIT如何，HEMO2life®组都有益处。Boostrap分析证实了这些结果。
结论：本研究表明，在OXYOP研究中使用HEMO2life®保留的肾脏中观察到的肾功能更好的恢复是这种突破性创新医疗设备的治疗益处。
方法：对OXYOP患者和ASTRE数据库中的患者（n=6584）进行了额外分析，以验证在HEMO2life®组中观察到的DGF率降低可能不仅是由于较短的CIT，而且还由于HEMO2life®表现。生成并比较两组肌酐水平低于250µmol/L的累积概率的Kaplan-Meier估计曲线。Cox模型用于测试解释变量的影响（使用HEMO2life®和CIT）。最后,使用引导策略随机选择较小的患者样本,并在ASTRE数据库中进行统计学比较.
结果：Kaplan-Meier估计曲线证实了DGF和CIT之间存在关系，而Cox分析显示，无论相关CIT如何，HEMO2life®组都有益处。Boostrap分析证实了这些结果。
结论：本研究表明，在OXYOP研究中使用HEMO2life®保留的肾脏中观察到的肾功能更好的恢复是这种突破性创新医疗设备的治疗益处。
