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

Conditions: Organ Transplant
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

Registration Number: EUCTR2011-000991-33-ES

Lead Sponsor: Instituto Aragonés de Ciencias de la Salud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

A) Donors
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

Exclusion Criteria

A) Donors
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.