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

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs072240126
Enrollment
2
Registered
2025-03-10
Start date
2025-03-10
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Liver disease indicated for liver transplantation

Interventions

Use of machine perfusion during the preservation of the liver graft for Liver Transplantation

Sponsors

Eguchi Susumu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Completion rate of machine perfsuion

Secondary

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

Contacts

Public ContactSusumu Eguchi

Nagasaki University Hospital

sueguchi@nagasaki-u.ac.jp+81-95-819-7316

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026