Can warming and supplying oxygen to a donor liver before transplantation improve the success of liver transplants?

Controlled Oxygenated Rewarming as Novel Endischemic Therapy for cold stored liver grafts (CORNET): a prospective randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN94691167

Enrollment

Registered

2018-11-05

Start date

2019-01-02

Completion date

Unknown

Last updated

2022-10-31

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

Conditions

Preservation and transplantation of liver grafts Surgery Liver transplant

Interventions

Randomisation: 1:1 block randomisation. The donor liver is randomised by our study design. Only patients who had given informed consent to participate in the study will be included in the randomisatio

100:147-52).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria for the recipient: 1. Aged =18 years 2. Indication for liver transplantation 3. Listed as 'transplantable' at Eurotransplant 4. Resident in Germany 5. Provided informed consent Inclusion criteria for donor liver: 1. Expanded criteria donor 2. Donor liver offered to the Transplantation Clinic Essen 3. Requiring one of the following criteria: 3.1. Age of donor >65 years 3.2. Intensive care including ventilation of the donor for >7 days 3.3. Obesity in the donor, i.e. BMI >30 kg/m2 3.4. Serum sodium >165 Mol/l, 3.5. Aspartate aminotransferase (AST/GOT) or alanine aminotransferase (ALT/GPT) >3 x normal 3.6. Serum bilirubin >3 mg/dl (last value prior to donor listing) 3.7. Liver steatosis (histologically confirmed) >40%

Exclusion criteria

Exclusion criteria: 1. High Urgency (HU) listing 2. Re-transplantation 3. Simultaneous participation in another preservation trial 4. Severe allergic diathesis 5. HIV-positive

Design outcomes

Primary

Measure	Time frame
Serum peak value of aspartate aminotransferase (AST) during the first 3 days after transplantation	—

Secondary

Measure	Time frame
1. Death assessed using patient medical records from admission until 3 months after transplantation 2. Early Allograft Dysfunction (EAD) according to Olthoff (bilirubin >10 mg/dl or INR >1.6 at POD 7, or peak-AST >2000 U/l during first week after transplantation, based on patient medical records from admission until 1 week after transplantation 3. Re-transplantation assessed using patient medical records from admission until 3 months after transplantation 4. Duration of stay in intensive care unit assessed using patient medical records 5. Ischemia reperfusion injury based on laboratory tests assessed using patient medical records from admission until 1 week after transplantation 6. Liver maximum function capacity assessed using LiMAx® test 1 day after transplantation 7. Evaluation of correlation of machine perfusion parameters (obtained during ex vivo machine perfusion) with ulterior graft function after transplantation as assessed using patient medical records from admission until 3 month after transplantation All patients are observed for 7 days following transplantation on a daily basis. Follow up includes additional observations on the day of discharge and 3 months after transplantation. Patients are followed until 3 months after the last patient is randomised for this trial and are asked to attend clinical routine follow up subsequent to termination of the study.	—

Measure

Time frame

1. Death assessed using patient medical records from admission until 3 months after transplantation 2. Early Allograft Dysfunction (EAD) according to Olthoff (bilirubin >10 mg/dl or INR >1.6 at POD 7, or peak-AST >2000 U/l during first week after transplantation, based on patient medical records from admission until 1 week after transplantation 3. Re-transplantation assessed using patient medical records from admission until 3 months after transplantation 4. Duration of stay in intensive care unit assessed using patient medical records 5. Ischemia reperfusion injury based on laboratory tests assessed using patient medical records from admission until 1 week after transplantation 6. Liver maximum function capacity assessed using LiMAx® test 1 day after transplantation 7. Evaluation of correlation of machine perfusion parameters (obtained during ex vivo machine perfusion) with ulterior graft function after transplantation as assessed using patient medical records from admission until 3 month after transplantation All patients are observed for 7 days following transplantation on a daily basis. Follow up includes additional observations on the day of discharge and 3 months after transplantation. Patients are followed until 3 months after the last patient is randomised for this trial and are asked to attend clinical routine follow up subsequent to termination of the study.

—

Countries

Germany

Outcome results

None listed

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