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Celsior versus University of Wisconsin preserving solutions for liver transplantation

Celsior versus University of Wisconsin preserving solutions for liver transplantation: a prospective randomised controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN82547607
Enrollment
102
Registered
2009-07-21
Start date
2001-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver transplantation Surgery Surgical operation and other surgical procedures

Interventions

1. Celsior preservation solution (experimental): N = 51 adult transplant recipients. Donor liver recovery was performed using conventional multi-organ procurement techniques. Celsior preservation sol

Sponsors

Aragon Health Science Institute (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adult liver transplant recipients 2. Minimum age: 18 years, maximum age: 70 years 3. Both sexes

Exclusion criteria

Exclusion criteria: Grafts procured in other centres by different surgical teams

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026