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Prospective randomised multicentre trial investigating liver preservation with Histidine-Tryptophan-Ketoglutarate (HTK) by simple aortic perfusion in comparison to aortic perfusion plus ex situ arterial flushing

Prospective randomised multicentre trial investigating liver preservation with Histidine-Tryptophan-Ketoglutarate (HTK) by simple aortic perfusion in comparison to aortic perfusion plus ex situ arterial flushing

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN78500982
Enrollment
174
Registered
2007-08-10
Start date
2007-07-09
Completion date
Unknown
Last updated
2021-11-08

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

Conditions

Liver transplantation after preservation in brain-death organ donors Surgery Transplantation surgery

Interventions

Aortic in situ perfusion versus aortic in situ perfusion plus arterial back-table ex situ flushing. At the beginning of the process of abdominal dissection, a tube is placed into the

Sponsors

Johannes Gutenberg University of Mainz (Germany)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: For the graft: 1. Liver graft retrieved in the Central Region of the German Foundation for Organ Transplantion (Region Mitte der Deutschen Stiftung Organtransplantation [DSO]) 2. Donor 18 - 80 years 3. Graft allocation to a participating centre For the recipient 1. Informed consent 2. Age 18 - 80 years 3. Standard criteria for liver transplantation (e.g. liver dysfunction because of cirrhosis, carcinoma)

Exclusion criteria

Exclusion criteria: For the graft: 1. Liver cirrhosis 2. Liver intoxication 3. Liver dysfunction 4. Liver trauma 5. Graft not transplantable (decision according to Standard Operating Procedures [SOP]) 6. Liver split For the recipient: 1. Standard criteria for liver transplantation

Design outcomes

Primary

MeasureTime frame
Rate of ITBL six months after transplantation.

Secondary

MeasureTime frame
1. Rate of ITBL or death within six months after transplantation 2. Parenchymal function following transplantation 3. Documentation and analysis of adverse events All secondary outcomes are measured within six months after transplantation.

Countries

Germany

Outcome results

None listed

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