Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-18 @ 6:11 PM
Study NCT ID:
NCT05206760
Status:
COMPLETED
Last Update Posted:
2022-01-25
First Post:
2021-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Severe Head Injury Brain Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Brain tissue CSF Blood Urine Saliva Faeces'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-24', 'studyFirstSubmitDate': '2021-05-20', 'studyFirstSubmitQcDate': '2022-01-24', 'lastUpdatePostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of brain biopsy', 'timeFrame': 'immediately after the intervention/procedure/surgery', 'description': 'Is it feasible to perform brain biopsy through ICP bolt or at time of craniotomy in TBI in order to obtain diagnostic tissue?'}, {'measure': 'Safety of brain biopsy', 'timeFrame': 'immediately after the intervention/procedure/surgery', 'description': 'Is it safe to perform brain biopsy through ICP bolt or at time of craniotomy in TBI?'}], 'secondaryOutcomes': [{'measure': 'Classification of TBI', 'timeFrame': 'immediately after the intervention/procedure/surgery', 'description': 'Classify TBI based on histopathological appearances'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Traumatic Brain Injury', 'Brain injury classification', 'Histology'], 'conditions': ['Brain Injury Traumatic Severe']}, 'descriptionModule': {'briefSummary': 'Safety and feasibility study investigating brain biopsy in severe head injury. When a patient undergoes craniotomy or ICP bolt insertion for trauma, a biopsy of brain tissue is taken.\n\nBlood, saliva, urine and faeces samples are also taken for 7 days following the brain biopsy.\n\nCSF is collected if a CSF drainage device is used.', 'detailedDescription': 'A minor amendment was submitted to allow histological and immunohistochemical analysis of the samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have suffered severe traumatic brain injury and require craniotomy or ICP bolt insertion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Severe traumatic brain injury -\n\nExclusion Criteria: Coagulopathy\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05206760', 'acronym': 'SHIBA', 'briefTitle': 'Severe Head Injury Brain Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Queen Mary University of London'}, 'officialTitle': 'Severe Head Injury Brain Analysis', 'orgStudyIdInfo': {'id': '271662'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Trial participants', 'description': 'Patients with severe traumatic brain injury requiring craniotomy or ICP bolt insertion', 'interventionNames': ['Procedure: Brain biopsy']}], 'interventions': [{'name': 'Brain biopsy', 'type': 'PROCEDURE', 'description': 'Biopsy of brain tissue', 'armGroupLabels': ['Trial participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E1 1FR', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Chris E Uff, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queen Mary University of London'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'Data are currently available. They will be available for 10 years (until 01/07/2031)', 'ipdSharing': 'YES', 'description': 'Data will be made available to other researchers on request. It is anticipated that this pilot study will result in further trials which will have greater data sharing potential.', 'accessCriteria': 'Apply directly to p.yup@qmul.ac.uk and c.uff@qmul.ac.uk'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Mary University of London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}