ISRCTN44414069已完成不适用
A prospective randomized single blind monocenter phase II study of organ perfusion with Custodiol-N compared with Custodiol solution in living donor kidney transplantation
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie/ Universitätsklinikum Essen0 个研究点目标入组 72 人开始时间: 2015年4月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. All indications for kidney transplantation as defined by local transplant law (TPG, Abs. 4, § 10)
- •2. Living donors should fulfill the criteria for living organ donation in accordance to local transplant law (TPG, Abs. 3, § 8)
- •3. Recipients awaiting their first transplant
- •4. Recipients = 18 years
- •5. The recipient’s signed informed consent of data use and protection before randomization
排除标准
- •1. Any contraindication for performance of a kidney transplantation as defined by local transplant law (TPG, Abs. 4, § 10)
- •2. Donors or recipients participating in another study involving compound/interventions aimed at the reduction of preservation and/or ischemia/reperfusion injury
- •3. Deceased donor kidney transplantation
- •4. Pregnant or lactating recipient patients
- •5. Female recipients of child-bearing potential who are not using a highly effective contraception method with a pearl-index <1
- •6. Multiorgan transplantation
- •7. Double kidney transplantation
- •8. Perfusion of the kidney by machine perfusion
- •9. Repeated kidney transplantation
- •10. Panel reactive antibodies > 85%
- •11.ABO incompatible kidney transplantation
- •12. Known hypersensitivity/anaphylaxis against iron chelators
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