Liver TransplantationPhase 2NCT00151593
Evaluation of Celsior® in Liver Transplant Preservation.
A Phase 2 study testing Celsior® in people with Liver Transplantation, run by Rennes University Hospital at 9 sites in France.
Trial summary
The aim of the study is to determine the efficacy and safety of a preservation solution in liver transplantation. Its efficacy will be compared to the efficacy of other currently used preservation solutions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Celsior®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 9 sitesFrance
- Study dates
- Feb 2002to Mar 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult
- Primary liver transplantation
- Whole organ transplantation
- Agreement for a 1 year follow-up
- Informed written consent
Who cannot join
- Liver disease secondary to clotting abnormalities
- Uncontrolled bacterial or viral disease at the time of transplantation
- Combined transplantations
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Service de Chirurgie Digestive - Hôpital de la Côte de Nacre
Caen, 14033
Service de Chirurgie Digestive - Hôpital Henri Mondor
Créteil, 94010
Service de Chirurgie Viscérale et Transplantations - Hôpital Dupuytren
Limoges, 87042
Chirurgie générale et digestive - Hôpital de la Croix Rousse
Lyon, 69317
Service de Chirurgie Générale - Hôpital Edouard Herriot
Lyon, 69437
Service de Chirurgie Générale - Hôpital de la Conception
Marseille, 13385
Service de Chirurgie Générale et Digestive - Hôpital Cochin
Paris, 75679
Département de Chirurgie Viscérale - Hôpital Pontchaillou
Rennes, 35033
Service de Chirurgie Générale et Transplantation Multi-organe - Hôpital de la Hautepierre
Strasbourg, 67098
About this study
Official title: Celsior®: Evaluation of an Organ Preservation Solution in Liver Transplantation.
The aim of the study is to determine the efficacy and safety of a preservation solution in liver transplantation. Its efficacy will be compared to the efficacy of other currently used preservation solutions.
Read the detailed description
The quality of organ preservation is a major determinant of initial graft function and survival. Graft viability is based on hypothermia, the organ being stored in a cold preservation solution.
Celsior® has been shown effective for cold preservation of heart and lung and, in laboratory studies, for liver, kidney and pancreas. The aim of the study is to evaluate the efficacy and safety of Celsior® in liver transplant preservation. Celsior® will be considered effective if the failure rate one year after transplantation is not significantly superior to 20% (rate observed in the European transplantation register between 1997 and 2001).
- Conditions
- Liver Transplantation
- Being tested
- Celsior®
- Keywords
- Cold storage, Liver transplantation, Preservation solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celsior®Other
Graft preservation solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Celsior preservation solution Receives: Other: Celsior® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft failure leading to patient death or retransplantation
Measured: 1 year
Secondary outcomes (6)
Onset and severity of hemodynamic troubles at reperfusion
Measured: Reperfusion after transplantation
Onset of surgical complications
Measured: 1 year
Liver graft function during the fourteen first days
Measured: 14 days
Incidence, treatment and evolution of acute and chronic rejections histologically proven
Measured: 1 year
Onset of infections
Measured: 1 year
Onset, treatment and evolution of serious adverse events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startFeb 2002
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sangstat Medical Corporation
- Investigators
- Karim Boudjema, MD, PhD, Study director, Rennes University HospitalEric Bellissant, MD, PhD, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151593
- Sponsor's protocol ID
- AFSSAPS 020007
- Other IDs
- LOC-H/01-04, CIC0203/006
- Status last verified
- Nov 2007
- First submitted
- 8 Sep 2005
- Last updated
- 26 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Karam G, Compagnon P, Hourmant M, Despins P, Duveau D, Noury D, Boudjema K. A single solution for multiple organ procurement and preservation. Transpl Int. 2005 Jun;18(6):657-63. doi: 10.1111/j.1432-2277.2005.00083.x.
PubMed 15910289Adam R, Cailliez V, Majno P, Karam V, McMaster P, Caine RY, O'Grady J, Pichlmayr R, Neuhaus P, Otte JB, Hoeckerstedt K, Bismuth H. Normalised intrinsic mortality risk in liver transplantation: European Liver Transplant Registry study. Lancet. 2000 Aug 19;356(9230):621-7. doi: 10.1016/s0140-6736(00)02603-9.
PubMed 10968434
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Celsior®: Evaluation of an Organ Preservation Solution in Liver Transplantation.
- ClinicalTrials.gov ID
- NCT00151593
- Acronym / sponsor ID
- AFSSAPS 020007
- Conditions
- Liver Transplantation
- Keywords
- Cold storage, Liver transplantation, Preservation solution
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Sangstat Medical Corporation
- Study start
- Feb 2002
- Study completion
- Mar 2006 (actual)
- First posted
- 9 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to determine the efficacy and safety of a preservation solution in liver transplantation. Its efficacy will be compared to the efficacy of other currently used preservation solutions.
Detailed description
The quality of organ preservation is a major determinant of initial graft function and survival. Graft viability is based on hypothermia, the organ being stored in a cold preservation solution.
Celsior® has been shown effective for cold preservation of heart and lung and, in laboratory studies, for liver, kidney and pancreas. The aim of the study is to evaluate the efficacy and safety of Celsior® in liver transplant preservation. Celsior® will be considered effective if the failure rate one year after transplantation is not significantly superior to 20% (rate observed in the European transplantation register between 1997 and 2001).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Celsior®Celsior preservation solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult
- Primary liver transplantation
- Whole organ transplantation
- Agreement for a 1 year follow-up
- Informed written consent
Key exclusion criteria (3 listed)
- Liver disease secondary to clotting abnormalities
- Uncontrolled bacterial or viral disease at the time of transplantation
- Combined transplantations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celsior®Graft preservation solution | Other | 1 |
Primary outcome
Graft failure leading to patient death or retransplantation
Time frame: 1 year
6 secondary outcomes
Onset and severity of hemodynamic troubles at reperfusion
Time frame: Reperfusion after transplantation
Onset of surgical complications
Time frame: 1 year
Liver graft function during the fourteen first days
Time frame: 14 days
Incidence, treatment and evolution of acute and chronic rejections histologically proven
Time frame: 1 year
Onset of infections
Time frame: 1 year
Onset, treatment and evolution of serious adverse events
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2007.
- Background: PubMed 15910289Karam G, Compagnon P, Hourmant M, Despins P, Duveau D, Noury D, Boudjema K. A single solution for multiple organ procurement and preservation. Transpl Int. 2005 Jun;18(6):657-63. doi: 10.1111/j.1432-2277.2005.00083.x.
- Background: PubMed 10968434Adam R, Cailliez V, Majno P, Karam V, McMaster P, Caine RY, O'Grady J, Pichlmayr R, Neuhaus P, Otte JB, Hoeckerstedt K, Bismuth H. Normalised intrinsic mortality risk in liver transplantation: European Liver Transplant Registry study. Lancet. 2000 Aug 19;356(9230):621-7. doi: 10.1016/s0140-6736(00)02603-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karim Boudjema, MD, PhD study director
Rennes University Hospital
Eric Bellissant, MD, PhD study chair
Rennes University Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celsior® in people with Liver Transplantation, run by Rennes University Hospital at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft failure leading to patient death or retransplantation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00151593, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2007.