Transcranial Doppler on Admission of Patients With Mild to Moderate Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

— TCD  

Official title:

Prospective, Multicentre, Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291706
• Other study ID #: DCIC 10 17
• Status: Completed
• Phase: N/A
• First received: February 7, 2011
• Last updated: April 25, 2014
• Start date: February 2011
• Est. completion date: December 2013

Study information

• Verified date: April 2014
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 369
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Device:
• Transcranial Doppler
Negative predictive value of transcranial doppler in patients with mild to moderate traumatic brain injury

Locations

Country	Name	City	State
France	CHRA Annecy	Annecy	Rhone Alpes
France	Ch Belley	Belley
France	CHU	Besancon
France	Ch Briancon	Briancon
France	Ch Cannes	Cannes
France	Ch Chambery	Chambery
France	CHU	Clermont Ferrand
France	CHU	Dijon
France	Ch Grasse	Grasse
France	CHU Grenoble	Grenoble	Isere
France	Chu Edouard Herriot	Lyon
France	CHU Lyon	Lyon
France	CHU Pierre Benite	Lyon
France	CH Nantes	Nantes
France	Chu Nimes	Nimes
France	Ch Saint Jean de Maurienne	Saint Jean de Maurienne
France	Hopitaux Du Pays Du Mont Blanc	Sallanches
France	Ch Saint Julien En Genevois	St Julien En Genevois
France	Ch Thonon Les Bains	Thonon Les Bains
France	CH Valence	Valence
France	Ch Voiron	Voiron

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	CIC Clinical Investigation Centre Grenoble

Country where clinical trial is conducted

France, 

References & Publications (11)

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. Epub 2006 Aug 8. — View 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. — View 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. Epub 2005 Apr 16. — View 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. — View 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.

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. — View 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. — View 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. Review. Erratum in: J Trauma. 2007 May;62(5):1309. — View 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. — View 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. — View Citation

White H, Venkatesh B. Applications of transcranial Doppler in the ICU: a review. Intensive Care Med. 2006 Jul;32(7):981-94. Epub 2006 May 10. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative predictive value of transcranial doppler	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.; Aggravation defined by: a decrease in the Glasgow Coma Scale of 2 points or more from the initial value, in the absence of pharmacological sedation.; a neurological deterioration sufficient to warrant intervention: mechanical ventilation, sedation, osmotherapy, barbiturates, transfer to more intensive care, or neurosurgical intervention.	within the first week after the injury	Yes
Secondary	the impact of transcranial doppler for initial patient management	Number of brain CTscan performed within 7 days after the trauma.; Number of devices inserted to monitor intracranial pressure.; Secondary admissions to intensive care unit.; Length of hospital stay.	within the first week after trauma	No
Secondary	Secondary neurological aggravation: risk factors and consequences.	Neurological outcome on day 7 and day 28 after trauma, as measured with disability rating scale.; Number and type of interventions for neurological deterioration	neurological outcome on D7 and D28	No

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