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

This study has been completed.
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: April 25, 2014
Last verified: April 2014
  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



Enrollment: 369
Study Start Date: February 2011
Study Completion Date: December 2013
Primary Completion Date: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Pierre Benite
Lyon, France
Chu Edouard Herriot
Lyon, France
CHU Lyon
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 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: April 25, 2014
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 September 11, 2014