Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-01 @ 11:41 AM
Study NCT ID:
NCT03062566
Status:
COMPLETED
Last Update Posted:
2019-04-24
First Post:
2016-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Potential of Prehospital Biomarkers in TBI Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-23', 'studyFirstSubmitDate': '2016-11-21', 'studyFirstSubmitQcDate': '2017-02-20', 'lastUpdatePostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mortality rates corresponding to se-S100B values', 'timeFrame': 'in relation to event within 1 year of trauma', 'description': 'survival versus death \\<7 days, 3 months and 6 months after trauma 6-month'}, {'measure': 'Mortality rates corresponding to se-GFAP values', 'timeFrame': 'in relation to event within 1 year of trauma', 'description': 'survival versus death \\<7 days, 3 months and 6 months after trauma 6-month'}, {'measure': 'Mortality rates corresponding to se-NSE values', 'timeFrame': 'in relation to event within 1 year of trauma', 'description': 'survival versus death \\<7 days, 3 months and 6 months after trauma 6-month'}, {'measure': 'Sensitivity of combined se-S100B, se-GFAP and se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable', 'timeFrame': 'in relation to event within 1 year of trauma'}, {'measure': 'Specificity of combined se-S100B, se-GFAP and se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable', 'timeFrame': 'in relation to event within 1 year of trauma'}, {'measure': 'Positive predictive value of combined se-S100B, se-GFAP and se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable', 'timeFrame': 'in relation to event within 1 year of trauma'}, {'measure': 'Negative predictive value of combined se-S100B, se-GFAP and se-NSE in relation to a binary outcome measured by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable', 'timeFrame': 'in relation to event within 1 year of trauma'}, {'measure': 'Biomarker dynamics between prehospital and in-hospital se-S100B values in relation to a binary outcome measured by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable', 'timeFrame': 'in relation to event within 1 year of trauma'}, {'measure': 'Biomarker dynamics between prehospital and in-hospital se-GFAP values in relation to a binary outcome measured by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable', 'timeFrame': 'in relation to event within 1 year of trauma'}, {'measure': 'Biomarker dynamics between prehospital and in-hospital se-NSE values in relation to a binary outcome measured by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable', 'timeFrame': 'in relation to event within 1 year of trauma'}, {'measure': 'Biomarker dynamics between prehospital and in-hospital combination of se-S100B, se-GFAP and se-NSE values in relation to a binary outcome measured by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable', 'timeFrame': 'in relation to event within 1 year of trauma'}], 'primaryOutcomes': [{'measure': 'Sensitivity of se-S100B in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable', 'timeFrame': 'in relation to event within 1 year', 'description': 'Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)'}, {'measure': 'Specificity of se-S100B in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable', 'timeFrame': 'in relation to event within 1 year', 'description': 'Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)'}, {'measure': 'Positive predictive value of se-S100B in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable', 'timeFrame': 'in relation to event within 1 year', 'description': 'Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)'}, {'measure': 'Negative predictive value of se-S100B in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable', 'timeFrame': 'in relation to event within 1 year', 'description': 'Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)'}], 'secondaryOutcomes': [{'measure': 'Sensitivity of se-GFAP in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable', 'timeFrame': 'in relation to event within 1 year', 'description': 'Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)'}, {'measure': 'Specificity of se-GFAP in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable', 'timeFrame': 'in relation to event within 1 year of trauma', 'description': 'Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)'}, {'measure': 'Positive predictive value of se-GFAP in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable', 'timeFrame': 'in relation to event within 1 year of trauma', 'description': 'Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)'}, {'measure': 'Negative predictive value of se-GFAP in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable', 'timeFrame': 'in relation to event within 1 year of trauma', 'description': 'Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)'}, {'measure': 'Sensitivity of se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable', 'timeFrame': 'in relation to event within 1 year of trauma', 'description': 'Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)'}, {'measure': 'Specificity of se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable', 'timeFrame': 'in relation to event within 1 year of trauma', 'description': 'Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)'}, {'measure': 'Positive predictive value of se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable', 'timeFrame': 'in relation to event within 1 year of trauma', 'description': 'Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)'}, {'measure': 'Negative predictive value of se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable', 'timeFrame': 'in relation to event within 1 year of trauma', 'description': 'Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['biomarkers', 'point-of-care analysis'], 'conditions': ['Traumatic Brain INjury']}, 'descriptionModule': {'briefSummary': 'The PreTBI III study aims to investigate the prognostic potential of prehospital and repeated in-hospital S100B, NSE and GFAP measurements as predictors of neurological outcome in patients suffering severe TBI. Knowledge on prehospital S100B, GFAP and NSE levels as predictors of neurological outcome and mortality may underline the potential of a point-of-care analysis. Possibly, the early biomarker levels may contributed to accurate monitoring of biomarker dynamics and hereby support neurosurgeons and anaesthetists in the clinical decision-making regarding treatment and level of care offered to the patient.\n\nHypotheses:\n\n1. Prehospital S100B level is a significant predictor of unfavourable neurological outcome (dichotomized disability rating scale (DRS) and glasgow outcome scale extended (GOS-E) measures) in severe TBI patients.\n2. Prehospital GFAP level is a significant predictor of unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients.\n3. Prehospital NSE level is a significant predictor of unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients.\n4. combined panel of prehospital S100B, GFAP and NSE levels is a significant predictor of unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients.\n5. Unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients can be predicted by dynamics in repeated measurements of S100B, GFAP and NSE.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients (≥18 years) suffering isolated head trauma and receiving an ambulance dispatched by the Prehospital Emergency Medical Services (EMS) in the Central Denmark Region.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting with Glasgow Coma Score (GCS) GCS 3-8 suffering relevant trauma and displaying relevant clinical indices compatible with TBI as evaluated by EMS staff. Patients are considered incompetent due to on-going alteration of mental state.\n\nExclusion Criteria:\n\n* \\>6 hours elapsed after trauma, unknown time of trauma, multi trauma, known dementia, chronic psychosis or active central nervous system (CNS) pathology.'}, 'identificationModule': {'nctId': 'NCT03062566', 'acronym': 'PreTBI III', 'briefTitle': 'Prognostic Potential of Prehospital Biomarkers in TBI Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Prognostic Potential of Prehospital S100B, Glial Fibrillary Acidic Protein (GFAP) and Neuron Specific Annuals (NSE) Levels in Patients Suffering Severe Traumatic Brain Injury (TBI)', 'orgStudyIdInfo': {'id': 'Protokol_v3_240816_PreTBI_III'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Severe TBI patients', 'description': 'GCS 3-8', 'interventionNames': ['Other: Blood sampling']}], 'interventions': [{'name': 'Blood sampling', 'type': 'OTHER', 'description': 'Blood sampling from peripheral venous catheter routinely inserted in trauma patients during transportation', 'armGroupLabels': ['Severe TBI patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N', 'country': 'Denmark', 'facility': 'Prehospital Emergency Medical Services, Central Denmark Region', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Central Denmark Region', 'class': 'OTHER'}, {'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}