Controlled oxygenated rewarming of liver grafts by ex-situ machine perfusion prior to transplantation

Controlled Oxygenated Rewarming as Adjunct in Liver transplantation (CORAL) of human allografts from extended criteria donors (ECD): a prospective randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15686690

Enrollment

Registered

2017-08-08

Start date

2017-07-31

Completion date

Unknown

Last updated

2018-12-04

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

Conditions

Preservation and implantation of liver grafts Surgery

Interventions

Randomisation: 1:1 block randomisation. The donor liver is randomized. Only patients who had given informed consent to participate in the study will be included in the randomization and the study.

100:147-52). 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 tra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Enhanced criteria donor according to recommendations of the German Medical Chamber: 1. Donor age > 65 years 2. Intensive therapy including assisted ventilation > 7 days 3. Obesity of donor (BMI > 30) 4. Serum Na > 165 Mol/l 5. GOT GPT > 3 x of normal 6. S-Bilirubin > 3 mg/dl 7. Liver steatosis (histologically proven) > 40% Patient: 1. Patient suffering from end-stage liver disease 2. Listed for liver transplantation 3. Signed informed consent 4. Age >18 years 5. Living in Germany

Exclusion criteria

Exclusion criteria: 1. HU-listed 2. Re-transplantation 3. Simultaneous participation in other preservation trial 4. HIV-positive 5. MELD score >25

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/6 month graft survival 2. Re-transplantation within 6 months after implantation 3. Time of stay in intensive care unit 4. Early Allograft Dysfunction (EAD) according to Olthoff (bilirubin>10mg/dl or INR >1.6 at POD 7, or peak-AST > 2000 U/L during first week after transplantation 5. Hepatic tissue perfusion measured 1h after revascularisation All patients are observed for seven days following transplantation on a daily basis. Follow up includes additional observations on the day of discharge and 3 month after transplantation. Patients are followed until 3 months after the last patient is randomized for this trial and are asked to attend clinical routine follow up subsequent to termination of the study.	—

Measure

Time frame

1. Death/6 month graft survival 2. Re-transplantation within 6 months after implantation 3. Time of stay in intensive care unit 4. Early Allograft Dysfunction (EAD) according to Olthoff (bilirubin>10mg/dl or INR >1.6 at POD 7, or peak-AST > 2000 U/L during first week after transplantation 5. Hepatic tissue perfusion measured 1h after revascularisation All patients are observed for seven days following transplantation on a daily basis. Follow up includes additional observations on the day of discharge and 3 month after transplantation. Patients are followed until 3 months after the last patient is randomized for this trial and are asked to attend clinical routine follow up subsequent to termination of the study.

—

Countries

Germany

Contacts

Public ContactAndreas Paul

Outcome results

None listed

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