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

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ClinicalTrials.gov Identifier: NCT01291706

Recruitment Status : Completed

First Posted : February 8, 2011

Last Update Posted : April 28, 2014

Sponsor:

Collaborator:

CIC Clinical Investigation Centre Grenoble

Information provided by (Responsible Party):

University Hospital, Grenoble

Study Description

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.

Condition or disease	Intervention/treatment
Traumatic Brain Injury	Device: Transcranial Doppler

Study Design


Study Type :	Observational
Actual Enrollment :	369 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Prospective, Multicentre, Observational Study
Study Start Date :	February 2011
Actual Primary Completion Date :	October 2013
Actual Study Completion Date :	December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Traumatic Brain Injury

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
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)	Device: Transcranial Doppler Negative predictive value of transcranial doppler in patients with mild to moderate traumatic brain injury

Outcome Measures

Primary Outcome Measures :

Negative predictive value of transcranial doppler [ Time Frame: within the first week after the injury ]
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.

Secondary Outcome Measures :

the impact of transcranial doppler for initial patient management [ Time Frame: within the first week after trauma ]
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.
Secondary neurological aggravation: risk factors and consequences. [ Time Frame: neurological outcome on D7 and D28 ]
Neurological outcome on day 7 and day 28 after trauma, as measured with disability rating scale.

Number and type of interventions for neurological deterioration

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	15 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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.

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291706

Locations


France
CHU Grenoble
Grenoble, Isere, France, 38043
CHRA Annecy
Annecy, Rhone Alpes, France, 74000
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 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, France

Sponsors and Collaborators

University Hospital, Grenoble

CIC Clinical Investigation Centre Grenoble

Investigators


Principal Investigator:	Jean Francois Payen, MD	University Hospital, Grenoble

More Information

Additional Information:

Username : DTC99 Password : DTCTST This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.


Responsible Party:	University Hospital, Grenoble
ClinicalTrials.gov Identifier:	NCT01291706 History of Changes
Other Study ID Numbers:	DCIC 10 17
First Posted:	February 8, 2011 Key Record Dates
Last Update Posted:	April 28, 2014
Last Verified:	April 2014

Keywords provided by University Hospital, Grenoble:


Transcranial Doppler Mild and moderate Traumatic Brain Injury Neurological deterioration Brain CT scan

Additional relevant MeSH terms:


Wounds and Injuries Brain Injuries Brain Injuries, Traumatic Brain Diseases	Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System

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