Evaluation of a Marine OXYgen Carrier: HEMO2Life® for hypOthermic Kidney Graft Preservation, Before Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- HEMO2Life® adverse effects
研究概览
简要总结
Kidney transplantation is the treatment of choice for end stage renal diseases, increasing life expectancy and quality of life. Improvement in organ preservation is a critical issue in this context.
This is a safety study evaluating the use of an oxygen carrier HEMO2Life® as an additive in organ preservation solution in kidney transplantation.
详细描述
Security of the use of HEMO2Life® will be analyzed by collecting all events within the first 3 months in terms of :
- HEMO2Life® adverse effects
- graft safety
- recipient safety (any adverse event) Accountability search will be achieved for each of these events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •For Kidney :
- •The first ten local kidneys in each participating centers that do not meet the exclusion criteria.
- •Graft retrieved in an adult donor
- •Graft from a deceased donor after brain death (DBD)
- •Graft locally transplanted in one of the 6 kidney transplant centers participating in the study
- •Graft stored in preservation solution containing HEMO2Life®
- •For Patient :
- •Patient who signed an inform consent form In case of patient unable to signed an inform consent form for patient under judicial protection (supervision, guardianship) the inform consent form will be obtain from the patient himself and from the supervisor/guardianshiper/parents, they will signed together the patient inform consent form.
- •The probability of the inclusion of a patient unable to signed an inform consent form is low but we can't know the receiver before conditioning the graft.
- •Patient > 18 years old
排除标准
- •Graft from a living donor
- •Graft from a donor after cardiovascular death (DCD)
- •Graft dedicated to a multi-organ transplantation
研究组 & 干预措施
Kidney transplantation
HEMO2Life® use in organ preservation solution. Grafts removed and transplanted locally within the 6 kidney transplant centers participating in the study will be preserved with Hemo2life.
干预措施: HEMO2Life® use in organ preservation solution (Procedure)
结局指标
主要结局
HEMO2Life® adverse effects
时间窗: During 3 months
All incidents and events of interest occurring during the use of HEMO2Life® will be collected
Graft safety
时间窗: During 3 months
Collecting any complication with particular attention to mascroscopic aspect, contamination of the conservation solution, surgical difficulties and thrombosis, primary non function, delayed graft function, slow recovery of graft function, acute rejection, or any other graft complications.
Recipient safety (any adverse event)
时间窗: During 3 months
All adverse events, even unrelated to HEMO2Life®, occuring during the first 3 months after transplantation will be collected. Vital signs and laboratory evaluations will be collected at D0, D1, D3, D7, D14, M1, M2 and M3 to evaluate the recipient safety
次要结局
- Histological evaluation of the graft on biopsies(pre-implantation to 3-month biopsies)
- Comparison of the graft survival criteria with a control population(Baseline to 12 months)
- Analysis of markers involved in kydney regeneration and neovascularization and markers of cellular stress.(Baseline to 12 months)