Celsior versus University of Wisconsin preserving solutions for liver transplantation

ISRCTN	ISRCTN82547607
DOI	https://doi.org/10.1186/ISRCTN82547607
Protocol serial number	PI07/49
Sponsor	Aragon Health Science Institute (Spain)
Funder	Aragon Health Science Institute (Spain)

Submission date: 31/05/2009
Registration date: 21/07/2009
Last edited: 21/07/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Francisco Agustínj García-Gil
Scientific

Hospital Clínico Universitario Lozano Blesa
Avda. San Juan Bosco, s/n
Zaragoza
50009
Spain

Study information

Primary study design	Interventional
Study design	Interventional single-centre prospective open-label randomised active-controlled two-arm parallel assignment phase IV trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Celsior versus University of Wisconsin preserving solutions for liver transplantation: a prospective randomised controlled study
Study objectives	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(s)	Clinical Research Ethics Committee of Aragon approved on the 17th October 2007 (ref: PI07/49)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Celsior preserving solutions, University of Wisconsin preserving solutions
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	70 Years
Sex	All
Target sample size at registration	102
Key inclusion criteria	1. Adult liver transplant recipients 2. Minimum age: 18 years, maximum age: 70 years 3. Both sexes
Key exclusion criteria	Grafts procured in other centres by different surgical teams
Date of first enrolment	01/01/2001
Date of final enrolment	31/12/2003

Locations

Countries of recruitment

Spain

Study participating centre

Hospital Clínico Universitario Lozano Blesa

Zaragoza
50009
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2006		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes