Condition category
Surgery
Date applied
31/05/2009
Date assigned
21/07/2009
Last edited
21/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Francisco Agustínj García-Gil

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

Aragon Health Science Institute (Spain)

Sponsor details

Avda. Gómez Laguna
25
Floor 11
Zaragoza
50009
Spain

Sponsor type

Government

Website

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

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17097942

Publication citations

  1. 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.

Additional files

Editorial Notes