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

This study is currently recruiting participants.
Verified March 2013 by University Hospital, Grenoble
Sponsor:
Collaborator:
CIC Clinical Investigation Centre Grenoble
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01291706
First received: February 7, 2011
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

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 Intervention
Traumatic Brain Injury
Device: Transcranial Doppler

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Multicentre, Observational Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Negative predictive value of transcranial doppler [ Time Frame: within the first week after the injury ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    Neurological outcome on day 7 and day 28 after trauma, as measured with disability rating scale.

    Number and type of interventions for neurological deterioration



Estimated Enrollment: 360
Study Start Date: February 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291706

Contacts
Contact: Jean Francois PAYEN, MD 33 4 76 76 56 35 JFPayen@chu-grenoble.fr
Contact: Carole Rolland 33 4 76 76 50 40 CarRolland@chu-grenoble.fr

Locations
France
CHU Grenoble Recruiting
Grenoble, Isere, France, 38043
Sub-Investigator: Christophe ROUX, MD         
Sub-Investigator: Julien BRUN, MD         
Principal Investigator: Pierre BOUZAT, MD         
Sub-Investigator: Philippe DECLETY, MD         
Sub-Investigator: Affif KADOUR, MD         
Sub-Investigator: Laurence SANDERS, MD         
Sub-Investigator: Jean Francois PAYEN, MD         
Sub-Investigator: Luc ALMERAS         
CHRA Annecy Recruiting
Annecy, Rhone Alpes, France, 74000
Principal Investigator: Albrice LEVRAT, MD         
Sub-Investigator: Renaud CHOUQUER, MD         
Ch Belley Not yet recruiting
Belley, France
Principal Investigator: Christophe RENARD, MD         
CHU Recruiting
Besancon, France
Principal Investigator: Marc GINET, MD         
Ch Briancon Recruiting
Briancon, France
Principal Investigator: Olivier BRIOT, MD         
Ch Cannes Not yet recruiting
Cannes, France
Principal Investigator: Djamel LAMECHE, MD         
Ch Chambery Recruiting
Chambery, France
Principal Investigator: Jean Marc THOURET, MD         
Sub-Investigator: Bernard ZERR, MD         
Sub-Investigator: Philippe BARBE, MD         
Sub-Investigator: Catherine CHASTAGNER, MD         
Sub-Investigator: Michel BADET, MD         
Sub-Investigator: Alexis SIMOND, MD         
Sub-Investigator: Matteo MIQUET, MD         
Sub-Investigator: Stephanie MAISON, MD         
Sub-Investigator: Stephane BARRE, MD         
CHU Recruiting
Clermont Ferrand, France
Principal Investigator: Thierry GILLART, MD         
Sub-Investigator: Dominique GUELON, MD         
Sub-Investigator: Michele BONNARD GOUGEON, MD         
Sub-Investigator: Russel CHABANNE, MD         
Sub-Investigator: Francois LONGERAS, MD         
CHU Recruiting
Dijon, France
Principal Investigator: Marc FREYSZ, MD         
Sub-Investigator: Didier HONNARD, MD         
Sub-Investigator: Aurelie GLOAGUEN, MD         
Sub-Investigator: Christophe SCHAEFER, MD         
Sub-Investigator: Sonia REGAD, MD         
Ch Grasse Recruiting
Grasse, France
Principal Investigator: Hichem CHENAITIA, MD         
CHU Pierre Benite Recruiting
Lyon, France
Principal Investigator: Jean Stephane DAVID, MD         
Chu Edouard Herriot Not yet recruiting
Lyon, France
Principal Investigator: Alexandre VULLIEZ, MD         
CHU Lyon Recruiting
Lyon, France
Principal Investigator: Etienne HAUTIN, MD         
CH Nantes Recruiting
Nantes, France
Principal Investigator: Karim ASEHNOUNE, MD         
Sub-Investigator: Jerome PAULUS, MD         
Sub-Investigator: Philippe PES, MD         
Chu Nimes Recruiting
Nimes, France
Principal Investigator: Xavier BOBBIA, MD         
Ch Saint Jean de Maurienne Recruiting
Saint Jean de Maurienne, France
Principal Investigator: Francois ALBASINI, MD         
Hopitaux Du Pays Du Mont Blanc Recruiting
Sallanches, France
Principal Investigator: Carron SCRIMGEOUR, MD         
Ch Saint Julien En Genevois Not yet recruiting
St Julien En Genevois, France
Principal Investigator: Cedric LUTZ, MD         
Ch Thonon Les Bains Not yet recruiting
Thonon Les Bains, France
Principal Investigator: Marine TASLE, MD         
CH Valence Not yet recruiting
Valence, France
Principal Investigator: Philippe BRUGE, MD         
Ch Voiron Recruiting
Voiron, France
Principal Investigator: Stephane FRENEA, MD         
Ch Voiron Recruiting
Voiron, France
Principal Investigator: Jerome NORMAND, MD         
Sponsors and Collaborators
University Hospital, Grenoble
CIC Clinical Investigation Centre Grenoble
Investigators
Principal Investigator: Jean Francois Payen, MD CHU Grenoble
  More Information

Additional Information:
Publications:
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.

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01291706     History of Changes
Other Study ID Numbers: DCIC 10 17
Study First Received: February 7, 2011
Last Updated: March 11, 2013
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by University Hospital, Grenoble:
Transcranial Doppler
Mild and moderate Traumatic Brain Injury
Neurological deterioration
Brain CT scan

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on April 21, 2014