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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01860716
Other study ID # PI10/02877
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received May 17, 2013
Last updated May 22, 2013
Start date May 2013
Est. completion date December 2013

Study information

Verified date May 2013
Source Aragon Institute of Health Sciences
Contact n/a
Is FDA regulated No
Health authority Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study type Interventional

Clinical Trial 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 encephalic death donors (EDD) in liver transplantation. The aim is to improve the functional quality of the retrieved organs, attenuate lesions and ischemia-reperfusion mediators, and provide grafts with greater resistance to post-transplant aggression.

METHODOLOGY. Prospective, randomized, double-blind, pilot trial to evaluate preconditioning with melatonin versus placebo in EDDs. Two groups, melatonin and control-placebo, n=30 per group. Administration to donor via NG tube of 30mg of melatonin or placebo (lactose) upon inclusion in the trial, 60 minutes prior to commencement of surgery and following laparotomy during extraction. Evaluation of response to treatment: A) Conventional clinical, hemodynamic, analytical and histopathological parameters in donor and recipient. B) Plasma determinations for: oxidative/nitrosative stress; acute phase proteins; cellular and humoral immunity; NT-proBNP and cystatin C; endocrine profile; melatonin levels. C) Determinations in liver tissue: quantification of malonyldialdehyde-4hydroxyalkenals and protein carbonyl content; cellular and mitochondrial membrane fluidity; markers of tissue-vascular damage and proliferation: transforming growth factor-beta (TGF-β); hypoxia-inducible factor (HIF) and vascular endothelial growth factor (VEGF). Data will be analyzed following a prospectively define plan and by intention-to-treat analysis.


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 Service). It will start in April-May 2013 and will finish 12 months later approximately. The study sponsor is I+CS (Aragon Institute of Health Sciences).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 68 Years
Eligibility 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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms

  • Evidence of Liver Transplantation

Intervention

Drug:
Melatonin
Melatonin 2 mg prolonged-release tablet, administration via nasogastric tube.
Placebo


Locations

Country Name City State
Spain Hospital Clínico Universitario Lozano Blesa Zaragoza

Sponsors (2)

Lead Sponsor Collaborator
Aragon Institute of Health Sciences Fondo de Investigacion Sanitaria

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary AST levels Aspartate transaminase (AST) levels will be measured. Between days 1 and 10 postoperatively. No
Primary ALT Alanine transaminase (ALT) levels will be measured. Between days 1 and 10 postoperatively No
Primary Bilirubin levels Bilirubin levels will be measured. Between days 1 and 10 postoperatively No
Primary Prothrombin levels Prothrombin levels will be measured. Between days 1 and 10 postoperatively No
Secondary Post-reperfusion syndrome Post-reperfusion syndrome Transplant day No
Secondary No primary function and primary graft dysfunction No primary function and primary graft dysfunction Transplant day No
Secondary Survival of the graft Survival of the graft From day 0 to 3 months No
Secondary Patient survival Patient survival Day 0 to 3 months No
Secondary Donor and recipient serological parameters Donor and recipient serological parameters Between days 1 and 10 postoperatively No
Secondary Morphological and functional quality of the liver graft evaluated by histological parameters of ischemia-reperfusion and tissue biochemical markers Morphological and functional quality of the liver graft evaluated by histological parameters of ischemia-reperfusion and tissue biochemical markers Day 0 and day 1 No
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