Safety of hypothermic oxygenated machine perfusion in iver transplantation with liver graft from brain-dead donor

JRCT ID: jRCTs072240126

Registered date:10/03/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Liver disease indicated for liver transplantation
• Date of first enrollment: 10/03/2025
• Target sample size: 2
• Study type: Interventional
• Intervention(s): Use of machine perfusion during the preservation of the liver graft for Liver Transplantation

Outcome(s)

• Primary Outcome: Completion rate of machine perfsuion

Secondary Outcome

Incidence of serious complications within 30 days
Incidence of Post-reperfusion syndrome
3-month graft survival rate

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Inclusion criteria at the time of consent explanation
(1) Patients scheduled to undergo liver transplantation at Nagasaki University Hospital
(2) Men or women 18 years of age or older at the time of consent
(3) Patients who have given their consent to participate in this study

Secondary inclusion criteria at the time of transplantation decision
(1) Patients whose transplantation has been decided
(2) Patients who have given verbal consent for the continuation of the study
(3) Donors who meet any of the following criteria
(a) 60 years of age or older
(b) expected cold ischemic time for more than 9 hours (including minimum HOPE duration of 1 hour)
(c) diagnosis of fatty liver by US/CT
(d) any of the following liver function abnormalities
- T.Bil highest value of 3 mg/dL or higher
- T.Bil immediately before 3 mg/dL or higher
- AST/ALT highest value of 1, 000 IU/L or more
- AST/ALT immediately preceding value of 100 IU/L or more

Exclude criteria

Exclusion criteria at the time of explanation
(1) When it is expected to be difficult to insert a perfusion tube due to the morphology or condition of the blood vessels.
(2) The patient's condition is unstable and it is judged that transplantation should be performed as soon as possible.
(3) For reasons other than the above, when the investigator judges that machine perfusion is undesirable based on an overall assessment of the patient's condition.

Secondary exclusion criteria at the time of transplantation decision
(1) The patient's intraoperative condition is unstable, and it is judged that transplantation should be performed as soon as possible.
(2) For reasons other than the above, the investigator judges that mechanical perfusion is undesirable based on a comprehensive judgment.

Related Information

• Primary Sponsor: Soyama Akihiko
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development