Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-02-25 @ 5:52 PM
Study NCT ID:
NCT01434056
Status:
UNKNOWN
Last Update Posted:
2011-09-14
First Post:
2011-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Mortality in Patients Waiting for Liver Transplantation Through Brain Magnetic Resonance Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058625', 'term': 'End Stage Liver Disease'}, {'id': 'D006501', 'term': 'Hepatic Encephalopathy'}, {'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-09-13', 'studyFirstSubmitDate': '2011-09-13', 'studyFirstSubmitQcDate': '2011-09-13', 'lastUpdatePostDateStruct': {'date': '2011-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Three months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Liver disease', 'Hepatic encephalopathy', 'MELD', 'Liver transplantation'], 'conditions': ['End Stage Liver Disease', 'Hepatic Encephalopathy']}, 'referencesModule': {'references': [{'pmid': '16498643', 'type': 'BACKGROUND', 'citation': 'Habib S, Berk B, Chang CC, Demetris AJ, Fontes P, Dvorchik I, Eghtesad B, Marcos A, Shakil AO. MELD and prediction of post-liver transplantation survival. Liver Transpl. 2006 Mar;12(3):440-7. doi: 10.1002/lt.20721.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether hepatic encephalopathy, measured through magnetic resonance imaging, electroencephalogram and neuropsychological evaluation adds prognostic information to patients who are waiting for liver transplantation. If this model improves mortality prediction this might be used in the future for organ allocation.', 'detailedDescription': "The only current definitive treatment for end-stage liver disease is transplantation. Due to the scarcity of organs available, the correct prioritization of patients for liver transplantation has a crucial importance. Nowadays, patients are ranked according to severity of liver disease, measured by the MELD score. This index is only derived from objective measures (serum concentration of bilirubin, creatinine and INR). Hepatic encephalopathy (HE) is a serious and progressive disorder in patients with end-stage liver disease. The severity of HE has prognostic implications in those waiting for liver transplantation. However, the prognosis of HE is independent and not correlated to the MELD score. Hepatic encephalopathy triggers multiple changes in brain magnetic resonance imaging (MRI) providing an objective way to evaluate it. Also electroencephalogram and neuropsychological evaluation might increase mortality prediction.\n\nAdding the information provided by MRI, electroencephalogram and neuropsychological evaluation to the MELD score model might increase the prediction of mortality. Increase mortality's prediction has a fundamental importance because in organ allocation.\n\nWe will evaluate the predictive value of these variables in predicting mortality of those patients waiting for liver transplantation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients waiting for liver transplantation with chronic end stage liver disease.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Man or woman over 18 years old\n* Listed in liver transplantation waiting line\n* Patient able and willing to participate in the evaluations of this study\n\nExclusion Criteria:\n\n* Acute liver failure\n* Serious structural brain anomalies\n* Condition or situation in which, in the opinion of the investigator, put the patient at significant risk'}, 'identificationModule': {'nctId': 'NCT01434056', 'briefTitle': 'Prediction of Mortality in Patients Waiting for Liver Transplantation Through Brain Magnetic Resonance Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Israelita Albert Einstein'}, 'officialTitle': 'Prediction of Mortality in Patients Waiting for Liver Transplantation Through Brain Magnetic Resonance Imaging', 'orgStudyIdInfo': {'id': '1341-11'}, 'secondaryIdInfos': [{'id': 'CEP1572', 'type': 'OTHER', 'domain': 'Ethical Committee Research'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Liver transplantation waiting list', 'description': 'Patients waiting for liver transplantation with chronic end staged liver disease'}]}, 'contactsLocationsModule': {'locations': [{'zip': '05652901', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'contacts': [{'name': 'Ellison F Cardoso, MD, PhD', 'role': 'CONTACT', 'email': 'ellisonfc@einstein.br', 'phone': '551121512487'}, {'name': 'Ellison F Cardoso, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Israelita Albert Einstein', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Ellison F Cardoso, MD, PhD', 'role': 'CONTACT', 'email': 'ellisonfc@einstein.br', 'phone': '551121512487'}], 'overallOfficials': [{'name': 'Edson Amaro Junior, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Israelita Albert Einstein'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Israelita Albert Einstein', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Ellison Fernando Cardoso', 'investigatorAffiliation': 'Hospital Israelita Albert Einstein'}}}}