Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT00151593
Status:
COMPLETED
Last Update Posted:
2007-11-26
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Celsior® in Liver Transplant Preservation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C088453', 'term': 'Celsior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-22', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2007-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Graft failure leading to patient death or retransplantation', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Onset and severity of hemodynamic troubles at reperfusion', 'timeFrame': 'Reperfusion after transplantation'}, {'measure': 'Onset of surgical complications', 'timeFrame': '1 year'}, {'measure': 'Liver graft function during the fourteen first days', 'timeFrame': '14 days'}, {'measure': 'Incidence, treatment and evolution of acute and chronic rejections histologically proven', 'timeFrame': '1 year'}, {'measure': 'Onset of infections', 'timeFrame': '1 year'}, {'measure': 'Onset, treatment and evolution of serious adverse events', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cold storage', 'Liver transplantation', 'Preservation solution'], 'conditions': ['Liver Transplantation']}, 'referencesModule': {'references': [{'pmid': '15910289', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10968434', 'type': 'BACKGROUND', 'citation': "Adam 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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nCelsior® 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult\n* Primary liver transplantation\n* Whole organ transplantation\n* Agreement for a 1 year follow-up\n* Informed written consent\n\nExclusion Criteria:\n\n* Liver disease secondary to clotting abnormalities\n* Uncontrolled bacterial or viral disease at the time of transplantation\n* Combined transplantations'}, 'identificationModule': {'nctId': 'NCT00151593', 'briefTitle': 'Evaluation of Celsior® in Liver Transplant Preservation.', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Celsior®: Evaluation of an Organ Preservation Solution in Liver Transplantation.', 'orgStudyIdInfo': {'id': 'AFSSAPS 020007'}, 'secondaryIdInfos': [{'id': 'LOC-H/01-04'}, {'id': 'CIC0203/006'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Celsior preservation solution', 'interventionNames': ['Other: Celsior®']}], 'interventions': [{'name': 'Celsior®', 'type': 'OTHER', 'description': 'Graft preservation solution', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'Service de Chirurgie Digestive - Hôpital de la Côte de Nacre', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Service de Chirurgie Digestive - Hôpital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Service de Chirurgie Viscérale et Transplantations - Hôpital Dupuytren', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69317', 'city': 'Lyon', 'country': 'France', 'facility': 'Chirurgie générale et digestive - Hôpital de la Croix Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69437', 'city': 'Lyon', 'country': 'France', 'facility': 'Service de Chirurgie Générale - Hôpital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'Service de Chirurgie Générale - Hôpital de la Conception', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '75679', 'city': 'Paris', 'country': 'France', 'facility': 'Service de Chirurgie Générale et Digestive - Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'Département de Chirurgie Viscérale - Hôpital Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de Chirurgie Générale et Transplantation Multi-organe - Hôpital de la Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Karim Boudjema, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHU Rennes'}, {'name': 'Eric Bellissant, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU Rennes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sangstat Medical Corporation', 'class': 'INDUSTRY'}]}}}