Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-30 @ 10:56 AM
Study NCT ID:
NCT05425251
Status:
UNKNOWN
Last Update Posted:
2024-10-02
First Post:
2022-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BRAINI-2 Elderly Mild TBI European Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'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': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2850}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2022-03-11', 'studyFirstSubmitQcDate': '2022-06-15', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biomarkers diagnostic performance', 'timeFrame': '12 hours after mild TBI', 'description': 'Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of GFAP and UCHL-1 used separately and in combination to detect the presence or absence of intracranial lesions on CT scan'}], 'secondaryOutcomes': [{'measure': 'Determination of the potential of the two biomarkers in predicting neurological symptoms after TBI', 'timeFrame': '1 week and 3 months', 'description': 'Early and midterm biomarker predictive performance in terms of predicting neurological outcome. Neurological status at 1 week and 3 months after TBI and Rivermead post concussion questionnaire.'}, {'measure': 'GFAP reference values', 'timeFrame': '1 Day, day of extraction of the sample', 'description': 'GFAP serum level distribution in the non-TBI reference population, considering age and comorbidities.'}, {'measure': 'UCHL-1 reference values', 'timeFrame': '1 Day, day of extraction of the sample', 'description': 'UCHL-1 serum level distribution in the non-TBI reference population, considering age and comorbidities.'}, {'measure': 'Determination of the potential of the two biomarkers in predicting neurological outcome assessed by the Extended Glasgow Outcome Score (GOSE) after TBI', 'timeFrame': '1 week and 3 months', 'description': 'Early and midterm biomarker predictive performance in terms of predicting neurological outcome. Extended Glasgow Outcome Score (GOSE)'}, {'measure': 'Determination of the potential of the two biomarkers in predicting quality of life assessed by Qolibri-OS after TBI', 'timeFrame': '1 week and 3 months', 'description': 'Early and midterm biomarker predictive performance in terms of predicting quality of life after mild TBI assessed by Qolibri-OS'}, {'measure': 'Determination of the potential of the two biomarkers in predicting quality of life assessed by EQ-5D-5L after TBI', 'timeFrame': '3 months', 'description': 'Midterm biomarker predictive performance in terms of predicting quality of life after mild TBI assessed by EQ-5D-5L'}, {'measure': 'Determination of the potential of the two biomarkers in depression symptoms assessed by PHQ-9 after TBI', 'timeFrame': '3 months', 'description': 'Midterm biomarker predictive performance in terms of predicting depression symptoms after mild TBI assessed by PHQ-9'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild Traumatic Brain Injury']}, 'referencesModule': {'references': [{'pmid': '37460257', 'type': 'DERIVED', 'citation': 'Lagares A, Payen JF, Biberthaler P, Poca MA, Mejan O, Pavlov V, Viglino D, Sapin V, Lassaletta A, de la Cruz J; Braini2_elderly_investigators Collaborative group. Study protocol for investigating the clinical performance of an automated blood test for glial fibrillary acidic protein and ubiquitin carboxy-terminal hydrolase L1 blood concentrations in elderly patients with mild traumatic BRAIN Injury and reference values (BRAINI-2 Elderly European study): a prospective multicentre observational study. BMJ Open. 2023 Jul 17;13(7):e071467. doi: 10.1136/bmjopen-2022-071467.'}]}, 'descriptionModule': {'briefSummary': 'Mild traumatic brain injury (mTBI) is one of the most frequent emergencies in the elderly population. Despite most mTBI are managed with cranial computed tomography (CT), only 10% of CTs show lesions, determining CT overuse. The use of serum glial fibrillary acidic protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) have shown potential for ruling out the need for cranial CT. However evidence on biomarker use in mild TBI were not based on studies that included aged participants and patients with comorbidities for which biomarker levels could vary. This is why there is a need for a prospective study that assesses the predictive performance of these two biomarkers in the elderly population, both in elderly patients suffering mild TBI and in a reference population, including patients and participants with and without comorbidities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '2370 participants suffering mild TBI; 480 non TBI participants.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BRAINI2-ELDERLY DIAGNOSTIC \\& PROGNOSTIC:\n\n * Patients ≥65 years of age\n * Mild TBI (GCS 13-15 on admission) with indication of brain CT scan in the 12 hours after injury ;\n * Blood sample obtained ≤12 h after injury and CT scan preferably ≤6h from blood sample.\n* BRAINI2-ELDERLY REFERENCE:\n\n * Non TBI patients ≥65 years of age\n\nExclusion Criteria:\n\n* BRAINI2-ELDERLY DIAGNOSTIC \\& PROGNOSTIC:\n\n * Age below 65 years.\n * GCS 3-12 on admission\n * Time of injury unknown\n * Time to injury exceeding 12 hours\n * Primary admission for non-traumatic neurological disorder (e.g., stroke, spontaneous, intracranial hematoma)\n * Penetrating head trauma\n * Patient with mechanical ventilation from the trauma scene or prehospital management.\n * Venipuncture not feasible\n * No realization of brain CT-scan\n * Subject under judiciary control\n * Subject in inclusion period of a drug interventional study\n* BRAINI2-ELDERLY REFERENCE:\n\n * Subject in inclusion period of another drug interventional study\n * Patients harboring a brain tumor\n * Patients that have had a stroke or neurosurgical operation 1 month prior to the inclusion in the study.'}, 'identificationModule': {'nctId': 'NCT05425251', 'acronym': 'BRAINI2ELDER', 'briefTitle': 'BRAINI-2 Elderly Mild TBI European Study', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario 12 de Octubre'}, 'officialTitle': 'Blood Biomarkers to Improve Management of Mild Traumatic BRAIN Injury in the Elderly', 'orgStudyIdInfo': {'id': 'HU 12Octubre'}, 'secondaryIdInfos': [{'id': 'EIT-HEALTH 220325', 'type': 'OTHER_GRANT', 'domain': 'European Institute of Innovation and Technology - EU co-fund'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'BRAINI2-ELDERLY DIAGNOSTIC & PROGNOSTIC', 'description': '2370 patients suffering mild Traumatic brain injury', 'interventionNames': ['Diagnostic Test: GFAP and UCH-L1']}, {'label': 'BRAINI2-ELDERLY REFERENCE', 'description': '480 non-tbi elderly reference patients', 'interventionNames': ['Diagnostic Test: GFAP and UCH-L1']}], 'interventions': [{'name': 'GFAP and UCH-L1', 'type': 'DIAGNOSTIC_TEST', 'description': '2x5mL blood samples will be used to determine the performance of the automated VIDAS TBI platform in assessing serum concentrations of GFAP and UCH-L1 to rule out the need for a CT-scan after mTBI.', 'armGroupLabels': ['BRAINI2-ELDERLY DIAGNOSTIC & PROGNOSTIC', 'BRAINI2-ELDERLY REFERENCE']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Vincent Sapin, PhD', 'role': 'CONTACT', 'email': 'vsapin@chu-clermontferrand.fr'}], 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Damien VIGNLINO, MD, PhD', 'role': 'CONTACT', 'email': 'DViglino@chu-grenoble.fr'}, {'name': 'Jean-François Payen, MD, PhD', 'role': 'CONTACT', 'email': 'Jean-Francois.Payen@univ-grenoble-alpes.fr'}], 'facility': 'CHU Grenoble-Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent JACQUIN, MD, PhD', 'role': 'CONTACT', 'email': 'laurent.jacquin@chu-lyon.fr'}], 'facility': 'Hôpital Edouard HERRIOT', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marion DOUPLAT, MD, PhD', 'role': 'CONTACT', 'email': 'Marion.douplat@chu-lyon.fr'}], 'facility': 'Hôpital Lyon Sud HCL', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Munich', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Peter Biberthaler, MD, PhD', 'role': 'CONTACT', 'email': 'Peter.Biberthaler@mri.tum.de'}, {'name': 'Fritz Seidl, PhD', 'role': 'CONTACT', 'email': 'fritz.seidl@tum.de'}], 'facility': 'Klinikum rechts der Isar', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '28041', 'city': 'Madrid', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alfonso L Lagares Gómez-Abascal, MD, PhD', 'role': 'CONTACT', 'email': 'alfonso.lagares@salud.madrid.org', 'phone': '+34917792389'}, {'name': 'Javier De la Cruz, MD', 'role': 'CONTACT', 'email': 'javier.delacruz@salud.madrid.org', 'phone': '+34917792644'}, {'name': 'Alfonso Lagares Gómez-Abascal, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'María Poca, MD, PhD', 'role': 'CONTACT', 'email': 'pocama@neurotrauma.net'}], 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Alfonso Lagares Gómez-Abascal, MD, PhD', 'role': 'CONTACT', 'email': 'alfonso.lagares@salud.madrid.org', 'phone': '+34917792839'}, {'name': 'Javier De la Cruz, MD', 'role': 'CONTACT', 'email': 'javier.delacruz@salud.madrid.org', 'phone': '+34917792644'}], 'overallOfficials': [{'name': 'Alfonso Lagares Gómez-Abascal, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario 12 de Octubre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario 12 de Octubre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Technical University of Munich', 'class': 'OTHER'}, {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, {'name': "Hospital Vall d'Hebron", 'class': 'OTHER'}, {'name': 'BioMérieux', 'class': 'INDUSTRY'}, {'name': 'EIT Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Neurosurgery, Head', 'investigatorFullName': 'Alfonso Lagares Gómez-Abascal', 'investigatorAffiliation': 'Hospital Universitario 12 de Octubre'}}}}