A Single Center Clinical Trial to Assess Viability of High Risk Donor Livers using Hypothermic and Normothermic Machine Perfusion with Rewarming Phase Prior to Transplantation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON19890

Enrollment

Registered

2016-07-19

Start date

2016-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

normothermic machine preservation normothermic machine perfusion ex-situ viability testing liver transplantation normotherme machine preservatie normtoherme machine perfusie lever transplantatie

Interventions

Each high risk donor liver accepted for this study will undergo machine perfusion. First, DHOPE will take place, before gradually rewarming the donor liver to a normothermic temperature. Secondly, af

Eligibility

Inclusion criteria

Inclusion criteria: Recipient -Adult patients (≥ 18 years old) -Given informed consent Donor grafts -Donors with a body weight ≥40 kg

Exclusion criteria

Exclusion criteria: Recipient -Simultaneous participation in another clinical trial that might possibly influence this trial -Mental conditions rendering the subject incapable to understand the nature, scope and consequences of the trial -Listed for liver transplantation due to fulminant liver failure or retransplantation because of PNF -Recipient tested positive for HIV Donor grafts -Donor tested positive for HIV, Hepatitis B or C -Split or partial liver grafts -Domino donor livers -Expected cold ischemia time of ≥ 10 hours (4)

Design outcomes

Primary

Measure	Time frame
The feasibility, and reliability of ex-situ viability testing of high risk donor livers using a protocol combining DHOPE, gradual rewarming and NMP, by assessing graft survival at 3 months after transplantation.	—

Secondary

Measure	Time frame
The feasibility, and reliability of ex-situ viability testing of high risk human donor livers using a protocol combining DHOPE, gradual rewarming and NMP, by assessing the following parameters: - Graft and patient survival at 7 days and 1 month. - Primary non-function (PNF): Occurrence of retransplantation or patient death within the first 7 days after OLT, without any identifiable cause of graft dysfunction 12. - Early allograft dysfunction (EAD), presence of one or more of the following variables 13: o Elevation of AST and/or ALT above a defined cut-off value (>2000 IU/mL ) within the first 7 days after Orthotopic Liver Transplantation (OLT); o Elevated international normalized ratio (INR) of ≥1.6 on day 7 after OLT; o Elevated bilirubin levels of ≥10 mg/dL on day 7 after OLT. - Development of non-anastomotic biliary strictures (NAS). - Biochemical analysis of graft function and ischemia-reperfusion injury determined with serum levels of ALT, AST, AlkP, γGT, INR, lactate, creatinine, platelets and total bilirubin at postoperative day 0-7 and 1 and 3 months.	—

Measure

Time frame

The feasibility, and reliability of ex-situ viability testing of high risk human donor livers using a protocol combining DHOPE, gradual rewarming and NMP, by assessing the following parameters: - Graft and patient survival at 7 days and 1 month. - Primary non-function (PNF): Occurrence of retransplantation or patient death within the first 7 days after OLT, without any identifiable cause of graft dysfunction 12. - Early allograft dysfunction (EAD), presence of one or more of the following variables 13: o Elevation of AST and/or ALT above a defined cut-off value (>2000 IU/mL ) within the first 7 days after Orthotopic Liver Transplantation (OLT); o Elevated international normalized ratio (INR) of ≥1.6 on day 7 after OLT; o Elevated bilirubin levels of ≥10 mg/dL on day 7 after OLT. - Development of non-anastomotic biliary strictures (NAS). - Biochemical analysis of graft function and ischemia-reperfusion injury determined with serum levels of ALT, AST, AlkP, γGT, INR, lactate, creatinine, platelets and total bilirubin at postoperative day 0-7 and 1 and 3 months.

—

Contacts

Public ContactY. de Vries

UMCG

y.de.vries@umcg.nl36305020235

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)