Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-27 @ 6:24 AM
Study NCT ID:
NCT05793203
Status:
RECRUITING
Last Update Posted:
2023-03-31
First Post:
2023-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single-center Prospective Study of Non-invasive Methods for the Diagnosis of Postoperative Complications in Liver Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-20', 'studyFirstSubmitDate': '2023-03-20', 'studyFirstSubmitQcDate': '2023-03-20', 'lastUpdatePostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early Allograft dysfunction (EAD)', 'timeFrame': '2 weeks from Liver transplantation', 'description': 'Olthoff criteria: bilirubina≥ 10 mg/dL in 7th post-operative day, international normalized ratio (INR) ≥ 1.6 in 7th post-operative day 7; ALT or AST\\> 2000 IU/L during the first 7 days after liver transplantation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rejection Acute Hepatic', 'Transplant; Failure, Liver', 'Liver Dysfunction']}, 'descriptionModule': {'briefSummary': 'A lot of different early and late complications may occur after liver transplantation. They could be related to surgical procedure, to infectious diseases or immuno-mediated diseases (acute cellular rejection, ACR). Almost all of those complications are characterized by an elevation in liver enzymes (ALT, AST and GGT) and a decline of liver function tests (serum bilirubin and INR increase) possibly leading to early allograft disfunction (EAD). In this scenario there is a lack of biomarker that could predict the development of ACR and/or EAD.\n\nThe aim of this study is to explore the prognostic role of non-invasive instrumental and biological marker in the early post-transplant phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients eligible for liver transplantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients eligible for liver transplantation following National and International Guidelines\n\nExclusion Criteria:\n\n* No agreement or inability to give informed consent\n\n * Re-transplant patients\n * Liver transplant in fulminant hepatitis'}, 'identificationModule': {'nctId': 'NCT05793203', 'acronym': 'ElastOLT', 'briefTitle': 'Single-center Prospective Study of Non-invasive Methods for the Diagnosis of Postoperative Complications in Liver Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Single-center Prospective Study of Non-invasive Methods for the Diagnosis of Postoperative Complications in Liver Transplant Recipients', 'orgStudyIdInfo': {'id': '4176'}}, 'contactsLocationsModule': {'locations': [{'zip': '00181', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Liguori, MD', 'role': 'CONTACT', 'email': 'lig.antonio91@gmail.com', 'phone': '+390630159223'}], 'facility': 'Fondazione Policlinico Universitario A. Gemelli IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Luca Miele, MD, PhD', 'role': 'CONTACT', 'email': 'luca.miele@policlinicogemelli.it', 'phone': '+390630151'}], 'overallOfficials': [{'name': 'Antonio Liguori, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Catholic University of the Sacred Heart'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}