Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PI07/49
Study information
Scientific title
Celsior versus University of Wisconsin preserving solutions for liver transplantation: a prospective randomised controlled study
Acronym
Study hypothesis
Celsior solution offers the same degree of safety and effectiveness as University of Wisconsin solution for liver transplantation.
Celsior solution is a high-sodium, low-potassium, and low-viscosity extracellular solution used for liver graft preservation. University of Wisconsin solution, an intracellular solution with high potassium content, has been universally accepted as the standard for the perfusion and storage of cold hepatic grafts.
The results of the pilot study have been published in 2003: http://www.ncbi.nlm.nih.gov/pubmed/12884193
Ethics approval
Clinical Research Ethics Committee of Aragon approved on the 17th October 2007 (ref: PI07/49)
Study design
Interventional single-centre prospective open-label randomised active-controlled two-arm parallel assignment phase IV trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Liver transplantation
Intervention
1. Celsior preservation solution (experimental):
N = 51 adult transplant recipients. Donor liver recovery was performed using conventional multi-organ procurement techniques. Celsior preservation solution cooled to 4°C was perfused by gravity through the aorta (4 L) and portal vein (2 L) in situ and on the back table through the portal vein (1 L). After recovery, the grafts were kept at 4ºC in conventional bags containing Celsior solution until transplantation. The liver transplant was performed preserving the retrohepatic vena cava (piggyback technique) without venovenous bypass. Before reperfusion, the graft was washed through the portal vein with 1200 ml cold Ringer's lactate. Reperfusion of the grafted liver was followed by hepatic arterial and biliary reconstruction. Total duration of follow-up: five years.
2. University of Wisconsin preservation solution (active comparator):
N = 51 adult transplant recipients. Donor liver recovery was performed using conventional multi-organ procurement techniques. University of Wisconsin preservation solution cooled to 4°C was perfused by gravity through the aorta (3 L) and portal vein (2 L) in situ and on the back table through the portal vein (1 L). After recovery, the grafts were kept at 4ºC in conventional bags containing University of Wisconsin solution until transplantation. The liver transplant was performed preserving the retrohepatic vena cava (piggyback technique) without venovenous bypass. Before reperfusion, the graft was washed through the portal vein with 1200 ml cold Ringer's lactate. Reperfusion of the grafted liver was followed by hepatic arterial and biliary reconstruction. Total duration of follow-up: five years.
Intervention type
Drug
Phase
Phase IV
Drug names
Celsior preserving solutions, University of Wisconsin preserving solutions
Primary outcome measure
1. Intra-operative mortality. Time Frame: intervention day.
2. Post-reperfusion syndrome. Time Frame: Intervention day. Post-reperfusion syndrome was defined as a decrease in the mean arterial pressure of more than 30% of the baseline value for more than one minute during the first five minutes after graft reperfusion. In relation to post-reperfusion syndrome, 17 intra-operatory variables were analysed, eight haemodynamic and nine metabolic. These variables were heart rate, mean arterial blood pressure, central venous pressure, mean pulmonary artery pressure, pulmonary capillary wedge pressure, cardiac output, systemic vascular resistance index, pulmonary vascular resistance index, central body temperature, arterial pH, standard bicarbonate, base excess, serum sodium, serum potassium, ionised calcium, magnesaemia, and glycaemia.
3. Primary non-function or primary dysfunction graft. Time Frame: first week post-liver transplantation. Primary non-function defined as the acute failure of the transplanted liver, leading to re-transplantation or death within seven days of the initial procedure, with no identifiable cause of graft failure. Primary dysfunction was defined as the elevation of transaminases 30-fold above normal and a prothrombin time greater than 20 seconds maintained for 3 days in the first week post-LT
4. Mortality during the first 30 days post-liver transplantation. Time Frame: 30 days post-liver transplantation.
5. Liver re-transplantation and causes. Time Frame: Five years post-liver transplantation.
6. Graft and patient survival during the follow-up period. Time Frame: 5 years post-liver transplantation.
Secondary outcome measures
1. Days in the Intense Care Unit. Time Frame: first 15 days post-liver transplantation.
2. Rates of acute rejection. Time Frame: Five years post-liver transplantation. Acute cellular rejection was proven by percutaneous liver biopsy.
3. Rates of chronic rejection. Time Frame: Five years post-liver transplantation. Chronic rejection was proven by percutaneous liver biopsy.
4. Infectious complications. Time Frame: Five years post-liver transplantation.
5. Vascular and biliary complications. Time Frame: Five years post-liver transplantation.
6. Values of aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT), bilirubin, and prothrombin activity. Time Frame: first 5 days post-liver transplantation.
Overall trial start date
01/01/2001
Overall trial end date
31/12/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adult liver transplant recipients
2. Minimum age: 18 years, maximum age: 70 years
3. Both sexes
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
102 adult transplant recipients
Participant exclusion criteria
Grafts procured in other centres by different surgical teams
Recruitment start date
01/01/2001
Recruitment end date
31/12/2003
Locations
Countries of recruitment
Spain
Trial participating centre
Hospital Clínico Universitario Lozano Blesa
Zaragoza
50009
Spain
Funders
Funder type
Government
Funder name
Aragon Health Science Institute (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17097942
Publication citations
-
Results
García-Gil FA, Arenas J, Güemes A, Esteban E, Tomé-Zelaya E, Lamata F, Sousa R, Jiménez A, Barrao ME, Serrano MT, Preservation of the liver graft with Celsior solution., Transplant. Proc., 2006, 38, 8, 2385-2388, doi: 10.1016/j.transproceed.2006.08.032.