FIRST BLOOD: this time he's fighting for his liver

Conditions: iverTransplantationDonation after Circulatory Death (DCD)Biliary ComplicationsHemodynamic StabilityEarly Allograft Disfunction (EAD)LeverTransplantatieDonatie na Circulatie ArrestGalweg ComplicatiesHemodynamische stabiliteitVroege Transplantaatfunctie

Registration Number: NL-OMON29265

Lead Sponsor: Erasmus MC Rotterdam

Brief Summary: 1. Jay C, Ladner D, Wang E, Lyuksemburg V, Kang R, Chang Y, et al. A comprehensive risk assessment of mortality following donation after cardiac death liver transplant - An analysis of the national registry. J Hepatol. 2011 Oct;55(4):808-13. 2. Jay CL, Lyuksemburg V, Kang R, Preczewski L, Stroupe K, Holl JL, et al. The increased costs of donation after cardiac death liver transplantation: caveat emptor. Ann Surg. 2011 Apr;251(4):743-8. 3. Jay CL, Lyuksemburg V, Ladner DP, Wang E, Caicedo JC, Holl JL, et al. Ischemic cholangiopathy after controlled donation after cardiac death liver transplantation: a meta-analysis. Ann Surg. 2011 Feb;253(2):259-64. 4. Farid WR, de Jonge J, Slieker JC, Zondervan PE, Thomeer MG, Metselaar HJ, et al. The importance of portal venous blood flow in ischemic-type biliary lesions after liver transplantation. Am J Transplant. 2011 Apr;11(4):857-62.

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

Age over 18 years of age
- On the active waiting list for liver transplantation
- Foreseen to be offered a donation after circulatory death (DCD) liver graft
- Written informed consent for this trial

Exclusion Criteria

- Contra-indications for DCD liver graft
- Split or reduced liver grafts
- Technical contra-indications to arterial reperfusion within 45 minutes (need for vascular reconstructions, jump grafting etc. during warm ischemic period)
- Multi-organ transplantation
- Pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of any biliary complication (leakage, non-anastomotic stricture (NAS) / Ischemia Type Biliary Lesion (ITBL), within the first year post-transplant, for which additional invasive intervention (ERCP, PTC), or drug therapy, other than prescription of ursodeoxicholic acid, is needed.

Secondary Outcome Measures

Name	Time	Method
A. Hemodynamic stability at reperfusion, measured as the area under the curve of vasoactive inotropic support in the first hour after reperfusion of the liver graft and the duration of mean arterial blood pressure below 60 mm Hg within the first hour of reperfusion.<br><br>B. Incidence of Early Allograft Dysfunction within the first week of liver transplantation, defined by the Olthoff Criteria