Cirrhotic patients receiving a primary liver transplant MedDRA version: 9.1 Level: LLT Classification code 10024667 Term: Liver cirrhosis
Conditions
Interventions
Trade Name: Somatostatine-UCB
Product Name: Somatostatine
Pharmaceutical Form: Powder and solvent for solution for injection
CAS Number: 51110-01-1
Other descriptive name: SOMATOSTATIN
Concentration u
Sponsors
University Hospital Ghent
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. b. To evaluate the reduction of ischemia-reperfusion injury (cytoprotective effect). c. To evaluate the efficacy of somatostatin in the prevention of the small-for-size syndrome (SFSS) in partial liver transplantation ;Primary end point(s): Patient systemic hemodynamics Intraoperative liver hemodynamics Flow velocity through the hepatic veins Ischemia-reperfusion injury | — |
Countries
Belgium
Outcome results
None listed