Organ Transplant
Conditions
Interventions
Trade Name: Circadin 2 mg comprimidos de liberación prolongada, blister de 21 comprimidos
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: MELATONINA
CAS Number: 73-31-4
Other descri
Sponsors
Instituto Aragonés de Ciencias de la Salud
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: General objective: To establish the efficacy of melatonin administered in the encephalic-death organ donor (EDD) and its influence on the evolution of liver transplant (LT). Primary specific objective: To compare liver graft function between the control and the melatonin group.;Primary end point(s): AST, ALT, bilirubin and prothrombin levels;Timepoint(s) of evaluation of this end point: Between days 1 and 10 postoperatively;Secondary Objective: To evaluate the influence of donor pretreatment with melatonin on: - Postoperative evolution of AST, ALT, bilirubin and INR. - Oxidative stress in the encephalic-death organ donor (EDD) and in the graft. - Circulating levels of pro- and anti-inflammatory cytokines in the EDD. - Plasma biomarkers of cardiac and renal function in the EDD and in the liver transplant (LT) recipient. - Dynamic response of acute phase proteins as markers of the intensity of the inflammatory reaction in the EDD and in the recipient. - General plasma endocrine response in the EDD and response of the renin-angiotensin-aldosterone system in the recipient. - Damage and tissue/vascular proliferation markers in hepatic tissue - Histological parameters of ischemia-reperfusion in the liver graft | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Evaluation according to the protocol description;Secondary end point(s): 1) Post-reperfusion syndrome 2) No primary function and primary graft dysfunction 3) Survival of the graft 4) Patient Survival 5) Donor and recipient serological parameters 6) Morphological and functional qualityof the liver graft evaluated by histological parameters of ischemia-reperfusion and tissue biochemical markers | — |
Countries
Spain
Contacts
Public ContactEva López Hernández
Instituto Aragonés de Ciencias de la Salud
Outcome results
None listed