Ignite Creation Date:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2026-01-22 @ 2:12 PM
Study NCT ID:
NCT03659006
Status:
UNKNOWN
Last Update Posted:
2018-10-23
First Post:
2018-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Predictive Neuroinflammatory Biomarkers of Neuro-radiological Evolution in Severe Traumatic Brain Injury
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2020-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-22', 'studyFirstSubmitDate': '2018-07-09', 'studyFirstSubmitQcDate': '2018-09-03', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interleukin-1 level in blood predict changes in brain volume assessed by quantitative MRI.', 'timeFrame': 'Day 42 and 12 months', 'description': 'Brain volume evolution assessed by quantitative MRI between Day 42 and Day 365'}], 'secondaryOutcomes': [{'measure': 'Concentrations of biomarkers such as Tau protein and beta-amyloid plaques in serum and cerebrospinal fluid (Aβ1-42, T-tau, and P-tau181P and Interleukin 1)', 'timeFrame': 'Blood and CSF samples collected at Day1, Day2, Day3, Day5 and Day7', 'description': 'Plasma and Serum biological collection, multimodal MRI database, clinical database'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['inflammatory Biomarkers, Traumatic brain injury, multimodal MRI, tertiary lesion'], 'conditions': ['Severe Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'Tertiary lesions responsible of the neurological decline after severe traumatic brain injury (TBI) are partially due to a persistent neuro-inflammation directly modulated by inflammatory mediators during the acute phase and detectable by using both multimodal MRI imaging and biological biomarkers during the acute phase after traumatic brain injury.\n\nThe main objective is to identify if the level of IL-1beta in cerebrospinal fluid predict in a reliable and reproducible way, the neuro-radiological evolution evaluated by the comparison of a quantitative MRI performed in post-resuscitation and at one year (quantitative ΔIRM) in traumatic brain injuried patients.\n\nThe secondary objectives are:\n\n* To understand the links between the acute and chronic neuro-inflammatory phase in a population of TBI,\n* To explore the contribution of the adaptive immune response in the persistent activation of the immune response,\n* To Examine the links between persistent neuroinflammation, clinical deterioration and neuroimaging,\n* To establish a correlation between the pathology and the physio-pathology of TBI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patient ≥ 18 years old at the time of inclusion\n2. Written and informed consent obtained from the family / proxy\n3. Patient hospitalized in neuro-ICU following severe TBI with GCS ≤ 8 at admission\n4. Intubated / ventilated patient scheduled for external ventricular bypass within 24 hours of hospitalization\n5. Absence of contraindications to perform an MRI\n6. Patient affiliated to a social security scheme (free State medical aid excluded)\n\nExclusion Criteria:\n\n1. Patient under protection of the law (guardianship or tutorship)\n2. TBI of ballistic origin\n3. Pregnant woman\n4. Pre-existing cerebral disease that can bias the MRI scan evaluation\n5. Contraindications to the MRI (pace maker, medical device incompatible with MRI, metal plates, ...)\n6. Patient with severe impairment of vital and / or life-threatening function with disability prior TBI\n7. Neurological antecedent susceptible to interfere with clinical evolution at one year\n8. Severe cardiogenic shock\n9. Severe respiratory impairment\n10. Extra-brain injuries involving immediate life-threatening\n11. Hemoglobin level below 9g / dL'}, 'identificationModule': {'nctId': 'NCT03659006', 'acronym': 'ICON-TBI', 'briefTitle': 'Identification of Predictive Neuroinflammatory Biomarkers of Neuro-radiological Evolution in Severe Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Identification of Predictive Neuroinflammatory Biomarkers of Neuro-radiological Evolution in Severe Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'K171201J'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biological Collection', 'description': 'Blood sampling on catheter and CSF sampling from VDE, multimodal MRI at D42 and D365, Neurological and neuropsychological evaluation at one year', 'interventionNames': ['Biological: Biological Collection']}], 'interventions': [{'name': 'Biological Collection', 'type': 'BIOLOGICAL', 'description': 'Blood sampling on catheter and CSF sampling from VDE, multimodal MRI at D42 and D365, Neurological and neuropsychological evaluation at one year', 'armGroupLabels': ['Biological Collection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'DEGOS Vincent, MD', 'role': 'CONTACT', 'email': 'vincent.degos@aphp.fr', 'phone': '0142163761'}], 'facility': 'Anesthesy department - Hôpital Pitié Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Vincent Degos, PU-PH', 'role': 'CONTACT', 'email': 'vincent.degos@aphp.fr', 'phone': '01 42 16 37 61'}, {'name': 'Gregory Torkomian, Master', 'role': 'CONTACT', 'email': 'gregory.torkomian@aphp.fr', 'phone': '01 42 16 37 01'}], 'overallOfficials': [{'name': 'Vincent Degos, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hopital Universitaire Robert-Debre', 'class': 'OTHER'}, {'name': 'University of Cambridge', 'class': 'OTHER'}, {'name': 'Mario Negri Institute for Pharmacological Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}