Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-28 @ 9:03 PM
Study NCT ID:
NCT01711957
Status:
UNKNOWN
Last Update Posted:
2012-10-24
First Post:
2012-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Perioperative Value of Platelet Counts in Predicting Outcome After Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003643', 'term': 'Death'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016031', 'term': 'Liver Transplantation'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D016377', 'term': 'Organ Transplantation'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-10-23', 'studyFirstSubmitDate': '2012-10-18', 'studyFirstSubmitQcDate': '2012-10-22', 'lastUpdatePostDateStruct': {'date': '2012-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient survival', 'timeFrame': '3-year'}], 'primaryOutcomes': [{'measure': 'Severe complication after liver transplantation', 'timeFrame': '90 days', 'description': 'The severity of complications will be graded according to the Clavien-Dindo classification by outcome. Grade III to V complications will be considered as severe.'}], 'secondaryOutcomes': [{'measure': 'Primary graft non-function', 'timeFrame': 'first postoperative week', 'description': 'Defined as death or retransplantation within the first postoperative week after exclusion of technical, immunological, and infectious causes'}, {'measure': 'Delayed graft function', 'timeFrame': '7 days after liver transplantation', 'description': 'Defined as the presence of at least one of the following parameter at 7 days after LT: serum bilirubin \\> 10 mg/dL and International Normalized Ratio (INR) \\>1.6 or Alanine aminotransferase serum level (ALT) \\>2000UI/L'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Complications', 'Mortality', 'Liver transplantation', 'Platelet count', 'Survival'], 'conditions': ['Complication', 'Death']}, 'referencesModule': {'references': [{'pmid': '24123804', 'type': 'DERIVED', 'citation': 'Lesurtel M, Raptis DA, Melloul E, Schlegel A, Oberkofler C, El-Badry AM, Weber A, Mueller N, Dutkowski P, Clavien PA. Low platelet counts after liver transplantation predict early posttransplant survival: the 60-5 criterion. Liver Transpl. 2014 Feb;20(2):147-55. doi: 10.1002/lt.23759. Epub 2013 Nov 21.'}]}, 'descriptionModule': {'briefSummary': 'Recent experimental and clinical studies have shown that platelets play a critical role in liver ischemia and regeneration. Thrombocytopenia, a frequent and potentially serious condition in liver transplantation (LT) recipients, was shown to be associated with postoperative morbidity and mortality after partial hepatectomy.\n\nThe investigators aim at evaluating whether postoperative low platelet counts are indicators of short- and long-term outcomes after liver transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with end stage liver disease and/or primary liver tumor undergoing liver transplantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years old\n* End stage liver disease\n* Cadaveric-donor liver transplantation\n\nExclusion Criteria:\n\n* Age \\<18 years old\n* Pregnancy\n* Living-related liver transplantation'}, 'identificationModule': {'nctId': 'NCT01711957', 'briefTitle': 'The Perioperative Value of Platelet Counts in Predicting Outcome After Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'The Perioperative Value of Platelet Counts in Predicting Outcome After Liver Transplantation', 'orgStudyIdInfo': {'id': 'EK-1487'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Liver disease and liver transplantation', 'description': 'Patient with end stage liver disease and/or primary liver tumor undergoing liver transplantation', 'interventionNames': ['Procedure: Liver transplantation']}], 'interventions': [{'name': 'Liver transplantation', 'type': 'PROCEDURE', 'otherNames': ['Orthotopic liver transplantation (OLT)', 'Cadaveric-donor liver transplantation'], 'description': 'Standardized technique of liver transplantation Organ procurement follow the rules of the Swiss transplant society', 'armGroupLabels': ['Liver disease and liver transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Department of Visceral Surgery and Transplantation', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Mickael Lesurtel, M.D., PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Zurich'}, {'name': 'Pierre-Alain Clavien, M.D., PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Zurich'}, {'name': 'Dimitri A. Raptis, M.D., MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}, {'name': 'Emmanuel Melloul, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Dimitri Aristotle Raptis', 'investigatorAffiliation': 'University of Zurich'}}}}