AzTrials
AzTrials

Traumatic Brain InjuryTCDNCT01291706

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

An observational study of Traumatic Brain Injury, run by University Hospital, Grenoble at 21 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Traumatic Brain Injury
What is being tested?
Transcranial Doppler
Type of treatment
Medical device
How many people
369 participants
Where
21 sitesFrance
Study dates
Feb 2011to Dec 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Primary admission of patients following mild to moderate traumatic brain injury who need exploration with brain CT scan.

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

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

France21 sites

  • CHRA Annecy

    Annecy, Auvergne-Rhône-Alpes, 74000

  • Ch Belley

    Belley

  • CHU

    Besançon

  • Ch Briancon

    Briançon

  • Ch Cannes

    Cannes

  • Ch Chambery

    Chambéry

  • CHU

    Clermont-Ferrand

  • CHU

    Dijon

  • Ch Grasse

    Grasse

  • CHU Grenoble

    Grenoble, Isere, 38043

  • Chu Edouard Herriot

    Lyon

  • CHU Lyon

    Lyon

  • CHU Pierre Benite

    Lyon

  • CH Nantes

    Nantes

  • Chu Nimes

    Nîmes

  • Ch Saint Jean de Maurienne

    Saint-Jean-de-Maurienne

  • Ch Saint Julien En Genevois

    Saint-Julien-en-Genevois

  • Hopitaux Du Pays Du Mont Blanc

    Sallanches

  • Ch Thonon Les Bains

    Thonon-les-Bains

  • CH Valence

    Valence

  • Ch Voiron

    Voiron

Other trials in France

About this study

Official title: Prospective, Multicentre, Observational Study

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.

Being tested
Transcranial Doppler
Keywords
Transcranial Doppler, Mild and moderate Traumatic Brain Injury, Neurological deterioration, Brain CT scan
Medical subject headings
Brain Injuries, Traumatic, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial DopplerDevice

    Negative predictive value of transcranial doppler in patients with mild to moderate traumatic brain injury

Study groups in NCT01291706
Study groupRoleWhat they receive
Mild TBI with mild lesions on CT scanNegative predictive value of transcranial doppler for patients with mild to moderate traumatic brain injury and mild brain lesions on initial CT scan (TCDB II)
Receives: Device: Transcranial Doppler

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: within the first week after the injury

Secondary outcomes (2)

  1. 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.

    Measured: within the first week after trauma

  2. 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

    Measured: neurological outcome on D7 and D28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionOct 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
369 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01291706
Sponsor's protocol ID
DCIC 10 17
Acronym
TCD
Status last verified
Apr 2014
First submitted
7 Feb 2011
Last updated
28 Apr 2014
Results posted
No
Data monitoring committee
No

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. doi: 10.1136/bmj.320.7250.1631.

    PubMed 10856063

  • 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.

    PubMed 17297312

  • 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.

    PubMed 10862205

  • 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.

    PubMed 11796768

  • 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.

    PubMed 17033552

  • 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.

    PubMed 16895944

  • 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.

    PubMed 16966987

  • 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.

    PubMed 16791661

  • 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.

    PubMed 9761044

  • 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.

    PubMed 15834704

Questions about this trial

What is this clinical trial studying?

An observational study of Traumatic Brain Injury, run by University Hospital, Grenoble at 21 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Negative predictive value of transcranial doppler (time frame: within the first week after the injury). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01291706, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2014.

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