Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-01-13 @ 8:27 AM
Study NCT ID:
NCT01291706
Status:
COMPLETED
Last Update Posted:
2014-04-28
First Post:
2011-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Doppler on Admission of Patients With Mild to Moderate Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], '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'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017585', 'term': 'Ultrasonography, Doppler, Transcranial'}], 'ancestors': [{'id': 'D004453', 'term': 'Echoencephalography'}, {'id': 'D009485', 'term': 'Neuroradiography'}, {'id': 'D059906', 'term': 'Neuroimaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D018608', 'term': 'Ultrasonography, Doppler'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 369}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-25', 'studyFirstSubmitDate': '2011-02-07', 'studyFirstSubmitQcDate': '2011-02-07', 'lastUpdatePostDateStruct': {'date': '2014-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Negative predictive value of transcranial doppler', 'timeFrame': 'within the first week after the injury', 'description': 'Patient with mild to moderate traumatic brain injury (Glasgow Coma Scale 9-15) and a CT scan (TCDB II).TCD is performed within 8 hours after the trauma.\n\nAggravation defined by:\n\n* a decrease in the Glasgow Coma Scale of 2 points or more from the initial value, in the absence of pharmacological sedation.\n* a neurological deterioration sufficient to warrant intervention: mechanical ventilation, sedation, osmotherapy, barbiturates, transfer to more intensive care, or neurosurgical intervention.'}], 'secondaryOutcomes': [{'measure': 'the impact of transcranial doppler for initial patient management', 'timeFrame': 'within the first week after trauma', 'description': 'Number of brain CTscan performed within 7 days after the trauma.\n\nNumber of devices inserted to monitor intracranial pressure.\n\nSecondary admissions to intensive care unit.\n\nLength of hospital stay.'}, {'measure': 'Secondary neurological aggravation: risk factors and consequences.', 'timeFrame': 'neurological outcome on D7 and D28', 'description': 'Neurological outcome on day 7 and day 28 after trauma, as measured with disability rating scale.\n\nNumber and type of interventions for neurological deterioration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Transcranial Doppler', 'Mild and moderate Traumatic Brain Injury', 'Neurological deterioration', 'Brain CT scan'], 'conditions': ['Traumatic Brain Injury']}, 'referencesModule': {'references': [{'pmid': '10856063', 'type': 'BACKGROUND', 'citation': 'Thornhill S, Teasdale GM, Murray GD, McEwen J, Roy CW, Penny KI. Disability in young people and adults one year after head injury: prospective cohort study. BMJ. 2000 Jun 17;320(7250):1631-5. doi: 10.1136/bmj.320.7250.1631.'}, {'pmid': '17297312', 'type': 'BACKGROUND', 'citation': 'Davis DP, Kene M, Vilke GM, Sise MJ, Kennedy F, Eastman AB, Velky T, Hoyt DB. Head-injured patients who "talk and die": the San Diego perspective. J Trauma. 2007 Feb;62(2):277-81. doi: 10.1097/TA.0b013e31802ef4a3.'}, {'pmid': '10862205', 'type': 'BACKGROUND', 'citation': 'Livingston DH, Lavery RF, Passannante MR, Skurnick JH, Baker S, Fabian TC, Fry DE, Malangoni MA. Emergency department discharge of patients with a negative cranial computed tomography scan after minimal head injury. Ann Surg. 2000 Jul;232(1):126-32. doi: 10.1097/00000658-200007000-00018.'}, {'type': 'BACKGROUND', 'citation': 'Marshall LF, Marshall SB, Klauber MR, van Berkum Clark M, Eisenberg HM, Jane JA, et al. A new classification of head injury based on computerized tomography. J Neurosurg 1991; 75: S14-S20.'}, {'pmid': '11796768', 'type': 'BACKGROUND', 'citation': 'Wardlaw JM, Easton VJ, Statham P. Which CT features help predict outcome after head injury? J Neurol Neurosurg Psychiatry. 2002 Feb;72(2):188-92; discussion 151. doi: 10.1136/jnnp.72.2.188.'}, {'pmid': '17033552', 'type': 'BACKGROUND', 'citation': 'Sifri ZC, Homnick AT, Vaynman A, Lavery R, Liao W, Mohr A, Hauser CJ, Manniker A, Livingston D. A prospective evaluation of the value of repeat cranial computed tomography in patients with minimal head injury and an intracranial bleed. J Trauma. 2006 Oct;61(4):862-7. doi: 10.1097/01.ta.0000224225.54982.90.'}, {'pmid': '16895944', 'type': 'BACKGROUND', 'citation': 'af Geijerstam JL, Oredsson S, Britton M; OCTOPUS Study Investigators. Medical outcome after immediate computed tomography or admission for observation in patients with mild head injury: randomised controlled trial. BMJ. 2006 Sep 2;333(7566):465. doi: 10.1136/bmj.38918.669317.4F. Epub 2006 Aug 8.'}, {'pmid': '16966987', 'type': 'BACKGROUND', 'citation': 'Stein SC, Burnett MG, Glick HA. Indications for CT scanning in mild traumatic brain injury: A cost-effectiveness study. J Trauma. 2006 Sep;61(3):558-66. doi: 10.1097/01.ta.0000233766.60315.5e.'}, {'pmid': '16791661', 'type': 'BACKGROUND', 'citation': 'White H, Venkatesh B. Applications of transcranial Doppler in the ICU: a review. Intensive Care Med. 2006 Jul;32(7):981-94. doi: 10.1007/s00134-006-0173-y. Epub 2006 May 10.'}, {'pmid': '9761044', 'type': 'BACKGROUND', 'citation': 'McQuire JC, Sutcliffe JC, Coats TJ. Early changes in middle cerebral artery blood flow velocity after head injury. J Neurosurg. 1998 Oct;89(4):526-32. doi: 10.3171/jns.1998.89.4.0526.'}, {'pmid': '15834704', 'type': 'BACKGROUND', 'citation': 'Jaffres P, Brun J, Declety P, Bosson JL, Fauvage B, Schleiermacher A, Kaddour A, Anglade D, Jacquot C, Payen JF. Transcranial Doppler to detect on admission patients at risk for neurological deterioration following mild and moderate brain trauma. Intensive Care Med. 2005 Jun;31(6):785-90. doi: 10.1007/s00134-005-2630-4. Epub 2005 Apr 16.'}], 'seeAlsoLinks': [{'url': 'https://www.clininfohosting.com/specif/DTC/', 'label': 'Username : DTC99 Password : DTCTST'}]}, 'descriptionModule': {'briefSummary': 'Patients with mild to moderate traumatic brain injury (TBI) are at risk for secondary neurological deterioration. Their outcome within the first week after injury could be predicted by clinical signs, brain CT scan and transcranial doppler (TCD) on admission to the emergency room. The investigators aim to evaluate the diagnostic performance of TCD to screen patients presented with mild to moderate TBI and mild lesions on CT scan, i.e., Trauma Coma Data Bank, TCDB classification II. The principal outcome measure is the negative predictive value of TCD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary admission of patients following mild to moderate traumatic brain injury who need exploration with brain CT scan.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Criteria for inclusion:\n\n* 15 years of age or more\n* primary admission for mild TBI (GCS 14-15) or moderate (GCS 9-13) TBI.\n* with or without multiple injury.\n* with no hemodynamic or respiratory distress: SAP \\>90mmHg, SPO2 \\>92%,hemoglobin \\> 8 g/dl.\n* with mild brain lesions on CTscan according to the traumatic coma data bank classification (TCDB) II: diffuse injury with cisterns present and no midline shift, mixed density lesions \\<25 ml.\n* Transcranial Doppler within 8 hours after the trauma.\n* patient affiliated to the social security system or equivalent\n\nCriteria for exclusion:\n\n* Severe TBI (GCS\\<9)\n* Penetrating TBI\n* patient with no brain CT scan\n* patient with normal brain CT scan (TCDB I), or severe brain CT scan (TCDB III-IV)\n* Hemodynamic or respiratory distress\n* Patient treated with anticoagulants: oral anticoagulant, heparin, anti-platelet agent (except Aspirin)\n* previous intracranial surgery\n* Patient with sedation and mechanical ventilation\n* transcranial Doppler unable\n* patient deprived of freedom by judicial or administrative decision\n* Follow up at 7 days impossible\n* Refusal consent to use data for statistics'}, 'identificationModule': {'nctId': 'NCT01291706', 'acronym': 'TCD', 'briefTitle': 'Transcranial Doppler on Admission of Patients With Mild to Moderate Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Prospective, Multicentre, Observational Study', 'orgStudyIdInfo': {'id': 'DCIC 10 17'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mild TBI with mild lesions on CT scan', 'description': 'Negative predictive value of transcranial doppler for patients with mild to moderate traumatic brain injury and mild brain lesions on initial CT scan (TCDB II)', 'interventionNames': ['Device: Transcranial Doppler']}], 'interventions': [{'name': 'Transcranial Doppler', 'type': 'DEVICE', 'description': 'Negative predictive value of transcranial doppler in patients with mild to moderate traumatic brain injury', 'armGroupLabels': ['Mild TBI with mild lesions on CT scan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74000', 'city': 'Annecy', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'CHRA Annecy', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'zip': '38043', 'city': 'Grenoble', 'state': 'Isere', 'country': 'France', 'facility': 'CHU Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Belley', 'country': 'France', 'facility': 'Ch Belley', 'geoPoint': {'lat': 45.75917, 'lon': 5.68813}}, {'city': 'Besançon', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Briançon', 'country': 'France', 'facility': 'Ch Briancon', 'geoPoint': {'lat': 44.89978, 'lon': 6.64201}}, {'city': 'Cannes', 'country': 'France', 'facility': 'Ch Cannes', 'geoPoint': {'lat': 43.55135, 'lon': 7.01275}}, {'city': 'Chambéry', 'country': 'France', 'facility': 'Ch Chambery', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Dijon', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Grasse', 'country': 'France', 'facility': 'Ch Grasse', 'geoPoint': {'lat': 43.65783, 'lon': 6.92537}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Chu Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'country': 'France', 'facility': 'CHU Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'country': 'France', 'facility': 'CHU Pierre Benite', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Nantes', 'country': 'France', 'facility': 'CH Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nîmes', 'country': 'France', 'facility': 'Chu Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'city': 'Saint-Jean-de-Maurienne', 'country': 'France', 'facility': 'Ch Saint Jean de Maurienne', 'geoPoint': {'lat': 45.27534, 'lon': 6.35293}}, {'city': 'Saint-Julien-en-Genevois', 'country': 'France', 'facility': 'Ch Saint Julien En Genevois', 'geoPoint': {'lat': 46.14434, 'lon': 6.08256}}, {'city': 'Sallanches', 'country': 'France', 'facility': 'Hopitaux Du Pays Du Mont Blanc', 'geoPoint': {'lat': 45.94423, 'lon': 6.63162}}, {'city': 'Thonon-les-Bains', 'country': 'France', 'facility': 'Ch Thonon Les Bains', 'geoPoint': {'lat': 46.37049, 'lon': 6.47985}}, {'city': 'Valence', 'country': 'France', 'facility': 'CH Valence', 'geoPoint': {'lat': 44.9256, 'lon': 4.90956}}, {'city': 'Voiron', 'country': 'France', 'facility': 'Ch Voiron', 'geoPoint': {'lat': 45.36471, 'lon': 5.5856}}], 'overallOfficials': [{'name': 'Jean Francois Payen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'CIC Clinical Investigation Centre Grenoble', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}