Celsior versus University of Wisconsin preserving solutions for liver transplantation
| ISRCTN | ISRCTN82547607 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82547607 |
| Secondary identifying numbers | PI07/49 |
- 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
Scientific
Hospital Clínico Universitario Lozano Blesa
Avda. San Juan Bosco, s/n
Zaragoza
50009
Spain
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2001 |
| Completion date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 102 adult transplant recipients |
| 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
50009
Spain
Sponsor information
Aragon Health Science Institute (Spain)
Government
Government
Avda. Gómez Laguna, 25
Floor 11
Zaragoza
50009
Spain
"ROR" |
https://ror.org/031n2c920 |
|---|
Funders
Funder type
Government
Aragon Health Science Institute (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
