Evaluate the Feasibility and Safety of Long-term Preservation of Human Livers before Transplantation.

Not Applicable

• Conditions: iver Transplantation; Liver Transplantation; Surgery - Other surgery; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12624000995572
• Lead Sponsor: Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Suitable potential LT-NMP trial graft recipients will be identified during their assessment and listing process. Eligible patients will be informed that they would be suitable to receive a graft from the NEOP trial. They will be given the patient information sheets to read more about the trial. If already listed, potential recipients will be identifiedt, contacted and sent the information documents. Informed consent will be obtained from all participants. Enrolling in the trial will not impact the chance of them receiving a standard ‘transplantable’ graft. Patients with all aetiologies of chronic liver disease will be considered for inclusion.
Recipients will meet all the following inclusion criteria to be eligible for participation in the NEOP trial:
•Adult primary liver transplant recipient.
•Patient listed electively (not ‘super-urgent) for transplantation.
•Low to moderate transplant risk candidate, suitable for extended criteria grafts, as assessed by the ANLTU liver transplant listing multidisciplinary team (MDT) meeting (these are usually candidates with MELD score < 20, without cardiovascular comorbidities, with good functional and nutrition status, with patent portal vein and with no history of previous major upper abdominal surgery, for example, patients transplanted for liver cancer).
•Able to undergo the informed consent process.

Exclusion Criteria

Recipient exclusion criteria
Subjects who meet any of the following exclusion criteria are excluded from participating in the NEOP trial:
•‘High-risk patients’ not considered suitable for a marginal graft (these are mainly patients with high MELD score (>20) with cardiovascular comorbidities or renal insufficiency, with poor nutrition and performance status).
•Patients with extensive portal vein thrombosis diagnosed prior to the transplantation.
•Liver re-transplantation.
•Patients with fulminant hepatic failure.
•Patients undergoing transplantation of more than one organ.

Study & Design

• Study Type: Interventional
• Study Design: Not specified