Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT05144451
Status:
UNKNOWN
Last Update Posted:
2022-04-14
First Post:
2021-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transcranial Doppler During Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017585', 'term': 'Ultrasonography, Doppler, Transcranial'}], 'ancestors': [{'id': 'D004453', 'term': 'Echoencephalography'}, {'id': 'D009485', 'term': 'Neuroradiography'}, {'id': 'D059906', 'term': 'Neuroimaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D018608', 'term': 'Ultrasonography, Doppler'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A single-arm trial involving 100 patients undergoing living donor liver transplantation; all will be examined using transcranial doppler to find out its predictive value on post-transplant neurological deficits.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2024-04-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-07', 'studyFirstSubmitDate': '2021-11-22', 'studyFirstSubmitQcDate': '2021-11-22', 'lastUpdatePostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-transplant Neurological Complication', 'timeFrame': '28 days after transplantation', 'description': 'incidence of Neurological Complication as a composite outcome (tremors, seizures, demyelination, posterior reversible encephalopathy syndrome, stroke)'}], 'secondaryOutcomes': [{'measure': 'flow patterns throughout the transplant surgery and in the ICU', 'timeFrame': 'intraoperative and 7 days after transplantion', 'description': 'normal, hyperemic, low-flow, or vasospastic flow by TCD'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Transplantation', 'Ultrasonography, Doppler, Transcranial', 'Complication, Postoperative', 'Neurologic Deficits']}, 'descriptionModule': {'briefSummary': 'This is a prospective study that would investigate the transcranial doppler (TCD) changes during the living donor liver transplantation and the association between the TCD changes and the post-transplant neurological complications.', 'detailedDescription': 'Objectives:\n\nParticipants \\& Setting:\n\nIntervention \\& Measurements:\n\nSample size:'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients scheduled for living donor liver transplantation for whatever the indication at Gastrointestinal surgery center (GISC)\n\nExclusion Criteria:\n\n* Patients with coexisting neuropsychiatric or cerebrovascular disorders or those who have a history of head trauma or brain surgery'}, 'identificationModule': {'nctId': 'NCT05144451', 'briefTitle': 'Transcranial Doppler During Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Transcranial Doppler and Neurological Complications After Liver Transplantation', 'orgStudyIdInfo': {'id': 'MD.21.09.535'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TCD arm', 'description': 'All patients will be evaluated with TCD for prediction of the post-transplant neurological complications', 'interventionNames': ['Diagnostic Test: Transcranial Doppler']}], 'interventions': [{'name': 'Transcranial Doppler', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['TCD'], 'description': 'Transcranial Doppler-derived parameters; pulsatility index (PI), resistance index (RI), mean flow velocity (Vmean) will be recorded before induction of anesthesia (T1).\n\nAfter induction, TCD parameters, Hemodynamic variables including heart rate (HR), invasive mean arterial blood pressure (MAP), and central venous pressure (CVP) together with Arterial blood gases (ABG analysis with values of PH, PCO2, PO2, blood oxygen saturation SO2 and bicarbonate HCO3), end-tidal carbon dioxide (ETCO2) and body temperature will be recorded too. Just before skin incision (T2), at the end of anhepatic phase 5 minutes before reperfusion (T3), 5 minutes after reperfusion (T4) and at the end of surgery (T5).\n\nPostoperatively at ICU, TCD parameters, Hemodynamic variables, and ABG will be obtained 24 hours postoperative (T6) and at discharge from ICU (T7).', 'armGroupLabels': ['TCD arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Mansoura University, Gastrointestinal Surgery Center, Liver Transplantation Unit', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Moataz M Emara, MD, EDAIC', 'role': 'CONTACT', 'email': 'mm.emara@mans.edu.eg', 'phone': '+201064048848'}, {'name': 'Kareem M Abozeid, MSc', 'role': 'CONTACT', 'email': 'kareemmohabozeid27@gmail.com', 'phone': '1557442411', 'phoneExt': '+20'}], 'overallOfficials': [{'name': 'Amr M Yassen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'timeFrame': 'will be updated', 'ipdSharing': 'YES', 'description': 'Data will be available with the corresponding author at reasonable request. The Data publishing with the manuscript will be discussed later.', 'accessCriteria': 'will be updated'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}