Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-02-26 @ 12:05 PM
Study NCT ID:
NCT03012633
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2017-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rapid Diagnostic of Hyperfibrinolysis in Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-15', 'studyFirstSubmitDate': '2017-01-05', 'studyFirstSubmitQcDate': '2017-01-05', 'lastUpdatePostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clot lysis time', 'timeFrame': 'during the liver transplantation surgery', 'description': 'clot lysis time obtained quickly with "Lysis Timer "is compared with standard laboratory tests to diagnose hyperfibrinolysis during liver transplantation surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hyperfibrinolysis, Lysis Timer'], 'conditions': ['Liver Transplantation']}, 'referencesModule': {'references': [{'pmid': '30282673', 'type': 'DERIVED', 'citation': 'Roullet S, Labrouche S, Mouton C, Quinart A, Nouette-Gaulain K, Laurent C, Freyburger G. Lysis Timer: a new sensitive tool to diagnose hyperfibrinolysis in liver transplantation. J Clin Pathol. 2019 Jan;72(1):58-65. doi: 10.1136/jclinpath-2018-205280. Epub 2018 Oct 3.'}]}, 'descriptionModule': {'briefSummary': 'During liver transplantation (LT), hyperfibrinolysis is one of the most important modification of haemostasis. It is associated with t-PA and protein C increased activity. Hyperfibrinolysis is frequent, hardly predictable and associated with major bleeding. The diagnostic of hyperfibrinolysis with standard laboratory tests (euglobulin lysis test, t-PA, PAI-1 and D-dimers dosages) does not provide an answer in a delay compatible with the clinical practice in the operating room.\n\nThe "Lysis Timer" is a device developed by Hyphen-Sysmex in collaboration with SD Innovation and Charleroi University Hospital (Belgium). It allows the implementation of the "Global Fibrinolytic Capacity", or GFC test, in a complete system associating i) the reagents for in vitro triggering of the clot and its lysis (contact system activators, t-PA, thrombin and calcium), ii) the signal acquisition by the Lysis Timer (able to convert the analogic signal of the absorbance modifications related to clot formation into a numeric signal) and iii) a dedicated software treating the numeric signal to define clot lysis time.\n\nThe GFC test, using t-PA to shorten signal acquisition times, is particularly adapted to the diagnosis of hyperfibrinolysis with PAI-1 collapse, of which LT is an example.', 'detailedDescription': 'The primary aim of this prospective, monocentric, observational study is to evaluate the Lysis Timer as a rapid diagnostic device for hyperfibrinolysis during liver transplantation. Lysis times provided by this device will be compared to the euglobulin lysis times and to the others parameters of fibrinolysis at the different stages of liver transplantation and more specifically at the anhepatic stage and after graft revascularization.\n\nThe secondary aims are to compare the results of the Lysis Timer, the thromboelastogram, the thrombin generation test and the standard laboratory tests in the context of hyperfibrinolysis during liver transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients benefiting from liver transplantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients benefiting from liver transplantation\n\nExclusion Criteria:\n\n* age under eighteen'}, 'identificationModule': {'nctId': 'NCT03012633', 'acronym': 'FILYTHO', 'briefTitle': 'Rapid Diagnostic of Hyperfibrinolysis in Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Rapid Diagnostic of Hyperfibrinolysis in Liver Transplantation', 'orgStudyIdInfo': {'id': 'DC 2016/142'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lysis timer', 'type': 'DEVICE', 'otherNames': ['Global Fibrinolytic Capacity', 'GFC test'], 'description': 'Lysis Timer compared with standard laboratory test to diagnose hyperfibrinolysis during liver transplantation.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'BORDEAUX UNIVERSITY HOSPITAL Haut Lévêque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}], 'overallOfficials': [{'name': 'Alexandre OUATTARA, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'head of anesthesia department II'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of department of Cardiovascular Anesthesia and Critical care', 'investigatorFullName': 'Alexandre OUATTARA', 'investigatorAffiliation': 'University Hospital, Bordeaux'}}}}