Clinical trial NCT01291706: Transcranial Doppler on Admission of Patients With Mild to Moderate Traumatic Brain Injury
Official title: Prospective, Multicentre, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: Transcranial Doppler
Mild and moderate Traumatic Brain Injury
Neurological deterioration
Brain CT scan
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: CIC Clinical Investigation Centre Grenoble
First posted: 2011-02-08
Enrollment: 369
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary admission of patients following mild to moderate traumatic brain injury who need exploration with brain CT scan.

Brief summary: 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.


Eligibility criteria: Criteria for inclusion:

* 15 years of age or more
* 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

Primary outcomes:
measure: Negative predictive value of transcranial doppler
timeFrame: within the first week after the injury
Secondary outcomes:
measure: the impact of transcranial doppler for initial patient management
timeFrame: within the first week after trauma
measure: Secondary neurological aggravation: risk factors and consequences.
timeFrame: neurological outcome on D7 and D28
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble
state: Isere
city: Annecy
country: France
facility: CHRA Annecy
state: Rhone Alpes
city: Belley
country: France
facility: Ch Belley
city: Besancon
country: France
facility: CHU
city: Briancon
country: France
facility: Ch Briancon
city: Cannes
country: France
facility: Ch Cannes
city: Chambery
country: France
facility: Ch Chambery
city: Clermont Ferrand
country: France
facility: CHU
city: Dijon
country: France
facility: CHU
city: Grasse
country: France
facility: Ch Grasse
city: Lyon
country: France
facility: Chu Edouard Herriot
city: Lyon
country: France
facility: CHU Lyon
city: Lyon
country: France
facility: CHU Pierre Benite
city: Nantes
country: France
facility: CH Nantes
city: Nimes
country: France
facility: Chu Nimes
city: Saint Jean de Maurienne
country: France
facility: Ch Saint Jean de Maurienne
city: Sallanches
country: France
facility: Hopitaux Du Pays Du Mont Blanc
city: St Julien En Genevois
country: France
facility: Ch Saint Julien En Genevois
city: Thonon Les Bains
country: France
facility: Ch Thonon Les Bains
city: Valence
country: France
facility: CH Valence
city: Voiron
country: France
facility: Ch Voiron
Study officials:
affiliation: University Hospital, Grenoble
name: Jean Francois Payen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.