Impact of melatonin in the pretreatment of organ donor and the influence in the evolution of liver transplant: a prospective, randomised double-blind study.

Instituto Aragonés de Ciencias de la Salud0 个研究点开始时间: 2012年3月28日最近更新: 2012年8月14日

试验速览

暂无简介。

•1. Encephalic-death (ED) organ donor who is situated in the ICUs of accredited hospitals in Zaragoza and meets each and every one of the following criteria.
•2. Being 16 years old or older.
•3. Informed consent for the donation signed by the immediate family.
•4. Informed consent for inclusion of the donor in the study .
•5. Receive intensive treatment and standard maintenance of the donor in ED, in accordance with universally accepted protocols of the Organizacion Nacional de Trasplantes (ONT), of the Aragon Autonomous Transplant Coordination, and of the ICUs and the participating hospitals in the study.
•B) Liver transplant recipients
•1. Being 18 years old or older and being less than 68 years of age.
•2. Informed consent for the procedure of LT signed.
•3. Informed consent for patient inclusion in the study, signed the same day that consent to the LT.
•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 60
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•A potential encephalic-death organ donor will not be included in the study if either of the following criteria:
•1. Absence of either signed informed consent: for organ donation or for inclusion in the study.
•2. No standard concomitant treatment and management of donor in ED.
•B) Liver transplant recipients
•1. Absence of either signed informed consent: for liver transplantation or for inclusion in the study.
•2. Split, domino or multiorgan transplantation.
•3. Grafts removed by other surgical teams.
•4. Pregnant women or fertile not using contraceptive measures highly effective.

发起方

Instituto Aragonés de Ciencias de la Salud