The study investigates how machine preservation methods protect and repair donor livers, and aims to understand which methods work best and why, so more of these higher-risk livers can be safely used for transplants

Mechanistic evaluation of machine perfusion strategies in donation after circulatory death liver transplantation

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15444108

Enrollment

Registered

2026-04-23

Start date

2025-03-25

Completion date

Unknown

Last updated

2026-05-19

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

Conditions

The patient population consists of adults listed for elective liver transplantation Digestive System

Interventions

Open-label, prospective, three-arm, phase II randomized clinical trial investigating the effects of 3 different preservation techniques on pre-defined functional and mechanistic endpoints in DCD liver

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Donor inclusion criteria: 1. DCD category III donors considered for abdominal organs-only retrieval 2. Donor age =18 years 3. Retrieval procedure allocated to the recruiting site’s NORS team 4. Donor liver accepted for a patient on the recruiting site’s transplant waiting list via the standard offering process 5. Donor BMI <35kg/m2 6. Predicted cold ischaemic time <8 hours 7. Donor family has given consent to use donated liver for research Recipient inclusion criteria: 1. Recipients 18 years of age or older 2. Listed on an elective transplant waiting list 3. Suitable to receive a DCD graft based on the liver listing MDT 4. Willing and able to consent for the study participation

Exclusion criteria

Exclusion criteria: Donor exclusion criteria (at the time of randomisation): 1. Donor is HIV, hepatitis B (HBV HbsAg) or hepatitis C (HCV RNA) positive 2. Any medical condition that, in the opinion of the principal investigator, would interfere with safe completion of the trial Donor exclusion criteria (at the time of retrieval): 1. Liver weight >2.5 kg 2. Macroscopic evidence of advanced fibrosis 3. Functional donor warm ischaemia (defined as a period between the systolic blood pressure 30 minutes 4. Any other clinical issue that in the opinion of the surgical team constitutes a contraindication to proceed with transplantation Recipient exclusion criteria: 1. High-risk surgical candidates (e.g. presence of extensive portomesenteric thrombosis, previous complex upper abdominal surgery) 2. Patients undergoing liver re-transplantation or multi-organ transplantation 3. Patients receiving super-urgent transplantation for acute and acute-on-chronic liver failure

Countries

England, United Kingdom

Contacts

Public ContactAlberto Sanchez-Fueyo

sanchez_fueyo@kcl.ac.uk+44 02078486910

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 22, 2026