A single center Phase-I Clinical Trial to Assess Viability of High Risk Donor Livers using Hypothermic and Normothermic Machine Perfusion with Rewarming Phase Prior to Transplantation

A single center Phase-I Clinical Trial to Assess Viability of High Risk Donor Livers using Hypothermic and Normothermic Machine Perfusion with Rewarming Phase Prior to Transplantation - Viability assessment of high risk donor livers using DHOPE, COR and NMP

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47272

Enrollment

Registered

2018-07-10

Start date

2016-12-01

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

end-stage liver disease

Interventions

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

controlled oxygenated rewarming

ex-situ viability testing

liver transplantation

normothermic machine perfusion

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:;Recipient - Adult patients (* 18 years old) - Given informed consent ;Donor grafts - Donors with a body weight *40 kg

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:;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 positive test for HIV - Allergic to one of the components in the perfusion fluid. ;Donor grafts - Donor positive for HIV, Hepatitis B or C - Split or partial liver grafts - Domino donor livers - Expected cold ischemia time of * 10 hours

Design outcomes

Primary

Measure	Time frame
The main study parameter is graft survival at 3 months after transplantation.	—

Secondary

Measure	Time frame
Secondary study 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 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, *GT, INR, lactate, creatinine, platelets and total bilirubin at postoperative day 0-7 and 1 and 3 months.	—

Measure

Time frame

Secondary study 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 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, *GT, INR, lactate, creatinine, platelets and total bilirubin at postoperative day 0-7 and 1 and 3 months.

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)