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

niversity Hospital Ghent0 个研究点开始时间: 2009年1月5日最近更新: 2015年8月17日

适应症

试验速览

暂无简介。

•- 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

•- 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.

发起方

niversity Hospital Ghent