A single-center, randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of Somatostatin used as inflow modulator in liver transplantation.

• Conditions: Cirrhotic patients receiving a primary liver transplant; MedDRA version: 9.1Level: LLTClassification code 10024667Term: Liver cirrhosis

• Registration Number: EUCTR2008-008319-24-BE
• Lead Sponsor: niversity Hospital Ghent

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-05
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Ability and willingness to provide written informed consent
- Cirrhotic patients with established clinically significant portal hypertension (CSPH) defined as an increase in hepatic venous pressure gradient to a threshold = 10 mmHg. The presence of varices, variceal haemorrhage and/or ascites, are indicative of the presence of CSPH. (De Franchis 2000)
- Recipients who are 18-70 years of age receiving a primary liver transplant from a brain death donor or living donor liver transplantation.
- Whole liver grafts and partial liver grafts can be included.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients who are recipients of multiple solid organ transplants, or have previously received an organ or tissue transplant.
- HIV positive patients.
- Patients with known history of portal thrombosis or diagnosed at the time of transplantation.
- Patients included in the preoperative assessment without a CSPH at the time of the first intraoperative measurement of portal pressure.
- Patients with low portal perfusion (=90 mL•min-1•100 gr of LV-1) measured at the time of operation. Portal flows above this limit can be excluded in the eventuality that, after infusion of somatostatin/placebo, the portal perfusion falls below 90 mL•min-1•100 gr of LV-1 .
- Patients with porto-pulmonary hypertension.
- Patients with known cardiac arrhythmias.
- Recipients of cardiac-death donors.
- Fulminant hepatic failure patients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and efficacy using somatostatin as portal vein flow and pressure modulator in liver transplantation in humans.;Secondary Objective: a. To elucidate pathophysiological pathways in non-cirrhotic grafted livers.<br>b. To evaluate the reduction of ischemia-reperfusion injury (cytoprotective effect).<br>c. To evaluate the efficacy of somatostatin in the prevention of the small-for-size syndrome (SFSS) in partial liver transplantation<br>;Primary end point(s): Patient systemic hemodynamics <br>Intraoperative liver hemodynamics <br>Flow velocity through the hepatic veins<br>Ischemia-reperfusion injury