HOPE for human livers
Phase 2
Recruiting
- Conditions
- iver transplantationSurgery
- Registration Number
- ISRCTN15527114
- Lead Sponsor
- niversity Hospital Zurich
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 170
Inclusion Criteria
1. Candidates for liver transplantation
2. Aged 18 or above
3. Receiving a whole liver graft
4. Full consent for the study
Exclusion Criteria
1. DCD livers
2. Split grafts
3. Living donor livers
4. Combined grafts
5. Domino liver transplantations
6. Cold storage of more than 12 hrs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major postoperative complications (Clavien Grade > or =III), using the established Clavien classification supported by a recently developed comprehensive complication index (CCI). Complications are summarized in the eCRF from the time of transplantation until 1 year after liver transplantation, which is the end of follow up. In the eCRF complications are monitored during hospital stay, at 3 and 6 and 9 and 12-month outpatient controls after liver transplantation.
- Secondary Outcome Measures
Name Time Method <br> 1. Plasma AST and ALT, measured 6 and 12 hours after OLT, and at day 1-7 postoperatively to determine the area under the curve (AUC)<br> 2. Postoperative liver function measured by INR (plasma, at day 1-7)<br> 3. Intra- and extrahepatic biliary complications within the first year after liver transplantation, assessed by serum cholestasis parameters (Bilirubin, Gammaglutamyltransferase, Alkaline Phosphatase) every 3 months and liver MRI including an MCRP 12 months after liver transplantation<br> 4. Length of hospital and ICU stay after transplantation<br> 5. Patient and graft survival at 1 year<br>