Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 11:08 PM
Study NCT ID:
NCT04641767
Status:
COMPLETED
Last Update Posted:
2022-02-22
First Post:
2020-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BIOmarkers of TRAumatic Brain Injury Spain (BIOTRABIS)
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-21', 'studyFirstSubmitDate': '2020-11-18', 'studyFirstSubmitQcDate': '2020-11-18', 'lastUpdatePostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain damage diagnostic accuracy', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Brain damage diagnostic in mild TBI patients during hospital admission \\[% brain damage versus % non brain damage\\] will be determined by clinical and neuroimaging criteria (CT) at emergency departments arrivals and compared with diagnostic accuracy of a blood biomarker based test.'}, {'measure': 'Brain damage long term diagnostic accuracy', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Brain damage diagnostic in mild TBI patients after 3 months \\[% brain damage long term versus % non brain damage long term \\] will be determined by Glasgow Outcome Score (GOSe) through telephone call and compared with previous diagnostic accuracy of a blood biomarker based test.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild Traumatic Brain Injury', 'Moderate Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': "Traumatic brain injury (TBI) is defined as a structural alteration of brain function caused by external causes, where mild traumatic brain injury (mTBI) represents approximately 80% of all TBI, and although its prognosis is relatively good, it represents a significant cost to the system due to the need to perform a cranial computed tomography (CT) scan, a test of high economic value and not without risks such as irradiation, especially important and dangerous in the pediatric age.\n\nThe investigators aim to set-up a point of-care (POC) device to validate a biomarker (H-FABP) able to diagnose the presence of brain damage in children and adults with mTBI at trauma and paediatric Emergency Departments using a blood sample, in order to save resources and avoid subjecting patients to a potentially damaging imaging test. But also, to assess whether the incorporation of new biomarkers improves the prediction of brain damage that can be done with H-FABP.\n\nFor that, the investigators will recruit a 400 patients' cohort with blood samples using the available POC device for H-FABP biomarker."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'BIOTRABIS\\> 18: Group that includes adult patients. Those with mild TBI will be recruited. In order to determine the severity of the TBI, the doctor uses a scale called the Glasgow GCS scale and mild TBI is understood as those with GCS: 14-15.\n\nBIOTRABIS \\<18: Group of pediatric patients. This will recruit those who come to the emergency department with mild TBI (GCS 14-15) or moderate (GCS 9-13).\n\nEach group is subdivided into pathological patients (those under study) or control patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'BIOTRABIS\\>18 (adult patients)\n\nInclusion Criteria:\n\n* Patients over 18 years old\n* Mild TBI patients the first 24 hours after trauma with GCS of 14-15 points.\n* Presence of any of the following symptoms:\n\n * Loss of consciousness less than 30 minutes, the first 20 minutes after trauma\n * Post-traumatic amnesia less than 24 hours, the first 30 minutes after trauma:\n * Persistent headache\n * Nausea / vomiting\n * Vertigo / dizziness\n * Confusion / disorientation\n\nExclusion Criteria:\n\n* Recent history (\\<1 month) of TBI\n* Refusal to participate in the study\n* Evidence of alcohol or other substance intoxication\n* Epilepsy\n* Schizophrenia\n\nBIOTRABIS\\<18 (paediatric patients)\n\nInclusion Criteria:\n\n* Patients between 0 and 17 years old.\n* Mild TBI (GCS 14-15) and moderate TBI (GCS 9-13) patients the first 24 hours after trauma.\n* Presence of any of the following symptoms:\n\n * Loss of consciousness less than 30 minutes, the first 20 minutes after trauma\n * Post-traumatic amnesia less than 24 hours, the first 30 minutes after trauma:\n * Persistent headache\n * Nausea / vomiting\n * Vertigo / dizziness\n * Confusion / disorientation\n\nExclusion Criteria:\n\n* Recent history (\\<1 month) of TBI\n* Refusal to participate in the study\n* Evidence of alcohol or other substance intoxication\n* Epilepsy\n* Schizophrenia'}, 'identificationModule': {'nctId': 'NCT04641767', 'acronym': 'BIOTRABIS', 'briefTitle': 'BIOmarkers of TRAumatic Brain Injury Spain (BIOTRABIS)', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Virgen Macarena'}, 'officialTitle': '"Fast Heart Fatty Acid Binding Protein (H-FABP) Determination to Rule Out Brain Damage in Mild Traumatic Brain Injury (TBI): the First Multicenter Study Using a Point of Care Device at Trauma and Pediatric Emergency Departments."', 'orgStudyIdInfo': {'id': 'BIOTRABIS_FMM-AP171562019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BIOTRABIS>18 - Pathologic patients', 'description': 'Group that includes adult patients under study. Those with mild TBI will be recruited. In order to determine the severity of the mild TBI, the doctor uses a scale called the Glasgow GCS scale and mild TBI is understood as those with GCS: 14-15.'}, {'label': 'BIOTRABIS>18 - Control patients', 'description': 'Group that includes adult control patients. Those with very mild TBI will be recruited (GCS: 15) without symptoms'}, {'label': 'BIOTRABIS<18 - Pathologic patients', 'description': 'Group of paediatric patients under study. This will recruit those who come to the emergency department with mild TBI (GCS 14-15) or moderate (GCS 9-13).'}, {'label': 'BIOTRABIS<18 - Control patients', 'description': 'Group that includes paediatric control patients. Those with very mild TBI will be recruited (GCS: 15) without symptoms'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08950', 'city': 'Esplugues de Llobregat', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Sant Joan Deu Barcelona', 'geoPoint': {'lat': 41.37732, 'lon': 2.08809}}, {'zip': '13600', 'city': 'Alcázar de San Juan', 'state': 'Ciudad Real', 'country': 'Spain', 'facility': 'Complejo Hospitalario La Mancha Centro', 'geoPoint': {'lat': 39.39011, 'lon': -3.20827}}, {'zip': '07120', 'city': 'Palma de Mallorca', 'state': 'Mallorca', 'country': 'Spain', 'facility': 'Hospital Universitario Son Espases', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '41013', 'city': 'Seville', 'state': 'Seville', 'country': 'Spain', 'facility': 'Hospital Virgen del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28009', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Infantil Niño Jesus', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '41009', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Virgen Macarena', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospitales Universitarios Virgen del Rocío', 'class': 'OTHER'}, {'name': 'Germans Trias i Pujol Hospital', 'class': 'OTHER'}, {'name': 'Hospital Sant Joan de Deu', 'class': 'OTHER'}, {'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}, {'name': 'Hospital Infantil Universitario Niño Jesús, Madrid, Spain', 'class': 'OTHER'}, {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, {'name': 'Complejo Hospitalario La Mancha Centro', 'class': 'OTHER'}, {'name': 'Hospital Son Espases', 'class': 'OTHER'}, {'name': 'Hospital Miguel Servet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Joan Montaner, MD, PhD', 'investigatorFullName': 'Joan Montaner Villalonga', 'investigatorAffiliation': 'Hospital Universitario Virgen Macarena'}}}}