Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2026-02-26 @ 12:41 AM
Study NCT ID:
NCT03396016
Status:
UNKNOWN
Last Update Posted:
2022-11-08
First Post:
2017-12-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasmatic Factor V as a Predictor of Graft Dysfunction After Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-07', 'studyFirstSubmitDate': '2017-12-27', 'studyFirstSubmitQcDate': '2018-01-04', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Factor V plasma level', 'timeFrame': 'day 1', 'description': 'Factor V plasma level'}, {'measure': 'Factor V plasma level', 'timeFrame': 'day 3', 'description': 'Factor V plasma level'}, {'measure': 'Factor V plasma level', 'timeFrame': 'Day 5', 'description': 'Factor V plasma level'}], 'secondaryOutcomes': [{'measure': 'Graft survival', 'timeFrame': '3 months', 'description': 'graft survival'}, {'measure': 'Graft survival', 'timeFrame': '6 months', 'description': 'graft survival'}, {'measure': 'Graft survival', 'timeFrame': '12 months', 'description': 'graft survival'}, {'measure': 'Patient survival', 'timeFrame': '3 months', 'description': 'patient survival'}, {'measure': 'Patient survival', 'timeFrame': '6 months', 'description': 'patient survival'}, {'measure': 'Patient survival', 'timeFrame': '12 months', 'description': 'patient survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Transplant Failure']}, 'descriptionModule': {'briefSummary': 'Factor V is a coagulation cofactor that is primarily produced by the liver. Previous data has suggested a correlation between factor V levels and graft dysfunction. The investigators hypothesize that Factor V may be a reliable biomarker for hepatic function after LT. Therefore, the aim of this study is to validate the use of Factor V as a predictor of graft dysfunction after LT. This is a single-center prospective validation study. Patients undergoing LT at the University Health Network will have plasmatic Factor V levels measured during postoperative week 1. Patients will be followed up to 12 months. The study outcomes will be early graft dysfunction, and graft and patient survival. Graft loss will be defined as need for retransplantation in the study period.', 'detailedDescription': 'There is no widely accepted biomarker to assess hepatic function after Liver Transplantation (LT). Factor V is a coagulation cofactor that is primarily produced by the liver. Factor V has a short half-life and its production does not depend on vitamin K, relying mainly on liver function. These singular characteristics make Factor V plasmatic levels strictly linked to liver function. Previous data has suggested a correlation between factor V levels and graft dysfunction. The investigators hypothesize that Factor V may predict graft dysfunction after LT, and become a reliable biomarker for hepatic function after LT. Therefore, the aim is to validate the use of Factor V as a predictor of graft dysfunction after LT. This is a single-center prospective validation study. Participants (patients undergoing LT at the University Health Network) will have plasmatic Factor V levels measured on postoperative days (POD) 1º, 2º, 3º, 5º and 7º. Participants will be followed up to 12 months. The study primary outcome will be early graft dysfunction as defined by Olthoff et al. Secondary outcomes will be 3-, 6- and 12-months graft and patient survival. Graft loss will be defined as need for retransplantation in the study period. Potential confounders will be assessed in a multivariate regression model. No other intervention will be done to the patients. The results of this study may validate the use of this biomarker for graft dysfunction and mortality after LT. These results will impact LT research and direct patient care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients awaiting a liver transplantation at University Health Network', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Listed for a deceased donor liver transplant at University Health Network\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Patients unable to provide informed consent\n* Recipients of live donor liver transplantation\n* Re-transplants\n* Recipients of multiple organs'}, 'identificationModule': {'nctId': 'NCT03396016', 'briefTitle': 'Plasmatic Factor V as a Predictor of Graft Dysfunction After Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Plasmatic Factor V as a Predictor of Graft Dysfunction After Liver Transplantation', 'orgStudyIdInfo': {'id': '17-6090'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Factor V', 'description': 'liver transplant patients having Factor V levels measured during their first postoperative week.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2N2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto General Hospital (University Health Network)', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Gonzalo Sapisochin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Surgical staff'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}