Status:
UNKNOWN
Impact of Melatonin in the Pretreatment of Organ Donor and the Influence in the Evolution of Liver Transplant.
Lead Sponsor:
Aragon Institute of Health Sciences
Collaborating Sponsors:
Fondo de Investigacion Sanitaria
Conditions:
Evidence of Liver Transplantation
Eligibility:
All Genders
18-68 years
Phase:
PHASE3
Brief Summary
Impact of melatonin on organ donor pretreatment and liver transplant recipient: prospective, randomized, double-blind trial. OBJECTIVES. To establish the efficacy of the melatonin administered to enc...
Detailed Description
This study will be done in the Hospital Clinico Lozano Blesa (Zaragoza, Spain), promoted by the Health Science Aragon Institute and its principal investigator is F. Agustín García Gil (Surgical Servic...
Eligibility Criteria
Inclusion
- A) Donors
- 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.
- Being 16 years old or older.
- Informed consent for the donation signed by the immediate family.
- Informed consent for inclusion of the donor in the study .
- 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
- Being 18 years old or older and being less than 68 years of age.
- Informed consent for the procedure of LT signed.
- Informed consent for patient inclusion in the study, signed the same day that consent to the LT.
Exclusion
- A) Donors
- A potential encephalic-death organ donor will not be included in the study if either of the following criteria:
- Absence of either signed informed consent: for organ donation or for inclusion in the study.
- No standard concomitant treatment and management of donor in ED.
- B) Liver transplant recipients
- Absence of either signed informed consent: for liver transplantation or for inclusion in the study.
- Split, domino or multiorgan transplantation.
- Grafts removed by other surgical teams.
- Pregnant women or fertile not using contraceptive measures highly effective.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01860716
Start Date
May 1 2013
End Date
December 1 2013
Last Update
May 23 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Zaragoza, Spain, 50009