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

Completed

• Conditions: Preservation and implantation of liver grafts; Surgery

• Registration Number: ISRCTN15686690
• Lead Sponsor: niversity Hospital Duisburg-Essen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-08
• Last Update Posted: 4 December 2018
• Study Completion: 2019-10-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum peak value of aspartate aminotransferase-AST during the first 3 days after transplantation

Secondary Outcome Measures

Name	Time	Method
<br> 1. Death/6 month graft survival<br> 2. Re-transplantation within 6 months after implantation<br> 3. Time of stay in intensive care unit<br> 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<br> 5. Hepatic tissue perfusion measured 1h after revascularisation<br><br> 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.<br>