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Marine oxygen carrier (M101) for organ preservation in liver transplantation; a randomised exploratory study.

The effect of marine oxygen carrier (M101) during cold static storage on the incidence of ischaemia reperfusion injury in liver transplantation; a randomised exploratory study.

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000301662
Enrollment
20
Registered
2023-03-17
Start date
2023-08-01
Completion date
2024-08-01
Last updated
2026-08-24

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

Conditions

None listed

Brief summary

Liver transplantation requires the donor liver to be stored for the period of time between being removed from the donor and transplanted into a recipient. This storage period can be up to 12 hours and during this time the liver does not receive any oxygen. Even though the liver is stored on ice, the lack of oxygen can result in injury to the liver cells and impair recovery after the transplant. M101 is a recently discovered oxygen carrying molecule with properties that make it very well suited for organ preservation. M101 will be added to the preservation fluid to provide oxygen during the period of storage, in order to prevent injury to liver cells from lack of oxygen. Studies in kidney transplantation found M101 to be safe and have a beneficial effect on kidney recovery after transplantation. M101 has also shown promising results in animal models of liver transplantation. However, it has not yet been tested in human liver transplantation. We would like to test whether adding M101 to the preservation fluid during storage of the donor liver improves liver function and patient recovery after the transplant. We will also assess whether M101 improves mitochondrial function (mitochondria are inside the liver cells and convert oxygen into the energy that the cells need to function) and modifies the immune response (which is activated by cell damage due to lack of oxygen). We hope that this research will lead to ways to improve the preservation of liver grafts used for transplantation, and that this will lead to better outcomes for patients.

Interventions

We will assess outcome after liver transplantation using grafts from deceased donors after brain death that have been perfused with University of Wisconsin solution (UWS) plus the oxygen carrier molecule M101 (HemO2life, Morlaix, France). M101 will be added to UWS that is flushed through the graft on a side table prior to cold static storage. All other donor and transplant procedures and post-transplant care will be standard in accordance with New Zealand Liver Transplant Unit protocol.

Sponsors

A/Prof Louise Barbier
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Standard criteria graft from brain death deceased donor Adult recipient of first liver transplant Able to give informed consent

Exclusion criteria

Donation after circulatory death or extended criteria graft Re-transplantation Acute liver failure Split liver transplant

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 31, 2026