Transcranial Doppler on Admission of Patients With Mild to Moderate Traumatic Brain Injury
NCT ID: NCT01291706
Last Updated: 2014-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
369 participants
OBSERVATIONAL
2011-02-28
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Mild TBI with mild lesions on CT scan
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)
Transcranial Doppler
Negative predictive value of transcranial doppler in patients with mild to moderate traumatic brain injury
Interventions
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Transcranial Doppler
Negative predictive value of transcranial doppler in patients with mild to moderate traumatic brain injury
Eligibility Criteria
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Inclusion Criteria
* primary admission for mild TBI (GCS 14-15) or moderate (GCS 9-13) TBI.
* with or without multiple injury.
* with no hemodynamic or respiratory distress: SAP \>90mmHg, SPO2 \>92%,hemoglobin \> 8 g/dl.
* 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.
* Transcranial Doppler within 8 hours after the trauma.
* patient affiliated to the social security system or equivalent
Criteria for exclusion:
* Severe TBI (GCS\<9)
* Penetrating TBI
* patient with no brain CT scan
* patient with normal brain CT scan (TCDB I), or severe brain CT scan (TCDB III-IV)
* Hemodynamic or respiratory distress
* Patient treated with anticoagulants: oral anticoagulant, heparin, anti-platelet agent (except Aspirin)
* previous intracranial surgery
* Patient with sedation and mechanical ventilation
* transcranial Doppler unable
* patient deprived of freedom by judicial or administrative decision
* Follow up at 7 days impossible
* Refusal consent to use data for statistics
15 Years
ALL
No
Sponsors
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CIC Clinical Investigation Centre Grenoble
UNKNOWN
University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Jean Francois Payen, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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CHRA Annecy
Annecy, Auvergne-Rhône-Alpes, France
CHU Grenoble
Grenoble, Isere, France
Ch Belley
Belley, , France
CHU
Besançon, , France
Ch Briancon
Briançon, , France
Ch Cannes
Cannes, , France
Ch Chambery
Chambéry, , France
CHU
Clermont-Ferrand, , France
CHU
Dijon, , France
Ch Grasse
Grasse, , France
Chu Edouard Herriot
Lyon, , France
CHU Lyon
Lyon, , France
CHU Pierre Benite
Lyon, , France
CH Nantes
Nantes, , France
Chu Nimes
Nîmes, , France
Ch Saint Jean de Maurienne
Saint-Jean-de-Maurienne, , France
Ch Saint Julien En Genevois
Saint-Julien-en-Genevois, , France
Hopitaux Du Pays Du Mont Blanc
Sallanches, , France
Ch Thonon Les Bains
Thonon-les-Bains, , France
CH Valence
Valence, , France
Ch Voiron
Voiron, , France
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Username : DTC99 Password : DTCTST
Other Identifiers
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DCIC 10 17
Identifier Type: -
Identifier Source: org_study_id
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