EUCTR2010-021333-31-DE进行中（未招募）不适用
Reduktion des Ischämie-Reperfusionsschadens durch ex-vivo Tacrolimus-Perfusion marginaler Organe vor Lebertransplantation (Tacrolimus-Organ-Perfusion TOP-Studie) - TOP-Studie
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Donor:organ donor with at least two of the following marginality criteria (according to Eurotransplant manual Extnded Criteria Liver Conors, 09/03/2009):
- •donors age>65
- •macro vesicular steatosis >40%
- •Na> 165 mmol/l
- •intensive care and ventilation >7 days
- •cold ischemia time >13 hours GPT>105 U/l GOT >99 U/l
- •Bilirubin >3mg/dl Bilirubin (> 51 µmol/l)
- •giving of adrenaline
- •listing for a liver transplantation at one of the participating sites
- •first liver transplantation
- •age >18 years
- •signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 82
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •at least one of the following riskfactors: active hepatitis B-or hepatitis C-infection
- •multi organ transplant
- •Extra hepatic tumor disease
- •refusal or withdrawal of the patient or their relatives
- •institutionalization based on official order or court order
- •missing or lacking knowledge of german, so that the understanding of the written patient information is not guaranteed
研究者
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