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A trial of different treatments on livers before transplantation

A study to evaluate the effects of different perfusion conditions during ex situ liver perfusion

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN36453355
Enrollment
150
Registered
2021-09-07
Start date
2021-08-01
Completion date
Unknown
Last updated
2025-01-28

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

Conditions

Liver transplantation Surgery

Interventions

This is a study of isolated livers undergoing normothermic perfusion ex situ (ex vivo). There are additional readouts for some groups) Study groups (n=6 to 10) will undergo incremental changes before

Sponsors

University of Cambridge
Lead Sponsor
Cambridge University Hospitals NHS Foundation Trust
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged =18 years 2. Requiring a liver transplant

Exclusion criteria

Exclusion criteria: 1. Lack of consent 2. Inability to comprehend the information

Design outcomes

Primary

MeasureTime frame
Transcriptomic profile measured using liver biopsies collected into RNA Later before and after 4 hours and at the end of liver perfusion and after reperfusion in the recipient

Secondary

MeasureTime frame
1. Transcriptomic signature measured using DESeq on biopsies of the liver taken pre-perfusion and after 4h, and at the end of perfusion and following reperfusion 2. Post transplant function: 2.1. Post reperfusion syndrome measured using mean blood pressure measured using an invasive arterial pressure monitor recording for the five minutes before and after reperfusion of the liver 2.2. Early allograft function measured using the model for early allograft function score which looks at recipient biochemical and haematological variables over the first 3 days post transplant 2.3. Early allograft function measured using L-GraFT7 score which looks at recipient biochemical and haematological variables over the first 7 days post transplant 2.4. Early allograft function measured using Olthoff score which looks at recipient biochemical and haematological variables over the first 7 days post transplant 2.5. Incidence of anastomotic and non-anastomotic structures in DCD livers measured using MRCP in the first 6 months post transplant 2.6. Peak creatinine d1-7 measured using serum creatinine measurements at baseline and the first 7 days post transplant 3. Perfusate chemistry: 3.1. TBARS measured using perfusate from the liver machine taken after 30mins and 4 hours of perfusion will be measured using a commercial kit 3.2. HMGB-1 measured using perfusate from the liver machine taken after 30mins and 4 hours of perfusion will be measured using a commercial kit 3.3. Hyaluronic acid levels measured using perfusate from the liver machine taken after 30mins and 4 hours of perfusion will be measured using a commercial kit 3.4. Uric acid measured using the Piccolo Express near patient analyser at 1, 2 and 4 hours 3.5. D-dimer concentration (thrombolysis group) measured on perfusate taken after 30mins and 4 hours of perfusion using a commercial assay kit Early allograft function and cholangiopathy are based on tests in the recipient post transplant; one post transplant biopsy for transc

Countries

England, United Kingdom

Contacts

Public ContactChris Watson
cjew2@cam.ac.uk+44 (0)1223216108

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026