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van CCT (UK)

van CCT (UK)

Hypothermic Oxygenated Perfusion of Liver Grafts Donated after Circulatory Death in Liver Transplantation - A Phase 1 Clinical Trial

- candidate number17191
- NTR NumberNTR4493
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-apr-2014
- Secondary IDsM14.152454 METc UMCG Groningen
- Public TitleHypothermic Oxygenated Perfusion of Liver Grafts Donated after Circulatory Death in Liver Transplantation - A Phase 1 Clinical Trial
- Scientific TitleSafety and Feasibility of End-ischemic Hypothermic Oxygenated Perfusion of Liver Grafts Donated after Circulatory Death in Liver Transplantation
- hypothesisTwo hours of end-ischemic hypothermic oxygenated perfusion via both the hepatic artery and the portal vein is feasible and safe in resuscitating liver grafts procured from donation after circulatory death donors.
- Healt Condition(s) or Problem(s) studiedLiver transplantation, Donation after Circulatory Death (DCD), Liver failure
- Inclusion criteriaAdult patients (> 18 years old) awaiting a liver transplantation and who have been allocated a liver graft from a DCD (Maastricht type 3) donor with a body weight of > 40 kg
- Exclusion criteriaPatients with mental conditions rendering then incapable to understand the nature, scope and consequences of the trial; listed as high urgency; positive test for HIV; pregnant or nursing; donor positive for hepatitis B or C; expected cold ischemia time of > 8 hours
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 6-apr-2014
- planned closingdate6-apr-2015
- Target number of participants6
- InterventionsLiver grafts transported to the transplantation hospital will be subjected to hypothermic oxygenated machine perfusion via the portal vein and hepatic artery after static cold storage and prior to implantation. The graft will be perfused for two hours using 3L of machine perfusion solution- Belzer UW (Bridge-to-Life, Ltd., Northbrook, IL, USA) with added glutathione (3 mmol/L). The system will be temperature (10-12C) and pressure controlled with the pressures limited to a mean of 25 mmHg at the hepatic artery and 3 mmHg at the portal vein. In this trial the Liver Assist (Organ Assist, Groningen, The Netherlands) will be used as perfusion machine.
- Primary outcomeThe primary endpoint of this trial will be graft survival within six months after DCD liver transplantation.
- Secondary outcome- Events during liver perfusion such as technical problems, duration of additional cold ischemia time
- Intraoperative events such as reperfusion syndrome, intraoperative blood loss or need for blood products transfusions
- Histology and ATP-content of liver and bile duct biopsies at the end of cold storage, after machine perfusion and after reperfusion
- Serum levels of ALT, AST, AlkP, GT, LDH, total bilirubin, albumin, total protein, sodium, potassium, calcium, CRP, INR, APTT, PT, fibrinogen, creatinine and urea measured during the first week after transplantation, before discharge, and at one, three, and six months after transplantation
- Post-transplant outcomes such as need for re-transplantation, duration of ICU and hospital stay
- Postoperative complications graded according to the Clavien-Dindo classification
- Reason, number, and duration of readmission within six months after transplantation
- Incidence of clinical and asymptomatic diagnosis of NAS within six months after transplantation confirmed by at least one imaging modality of the bile duct such as endoscopic retrograde cholangiopancreatography (ERCP), magnetic resonance cholangiopancreatography (MRCP), percutaneous transhepatic cholangiogram (PTC) or conventional cholangiography
- Number and type of interventions needed due to occurrence of NAS such as ERCP or re-transplantation within six months after transplantation
- Timepoints- At patient inclusion
- Before liver transplantation
- Before hypothermic machine perfusion
- After hypothermic machine perfusion
- After reperfusion in the patient
- Posttransplantation at day 0 - 7, day of discharge, 1 month, 3 months and 6 months
- Trial web site
- statusinclusion stopped: follow-up
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summaryThis is a single center, prospective, non-randomized phase-I clinical trial to evaluate safety and feasibility of two hours of hypothermic oxygenated perfusion via portal vein and hep.atic artery at the end of static cold storage and before implantation. Six DCD liver grafts that are accepted for transplantation will be subjected to the intervention and the recipients will be followed for duration of six months posttransplantation. Primary endpoint is graft survival within six months
- Main changes (audit trail)
- RECORD6-apr-2014 - 23-jan-2015

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