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

April 25, 2014 updated by: University Hospital, Grenoble

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

369

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Belley, France
        • Ch Belley
      • Besancon, France
        • CHU
      • Briancon, France
        • CH Briançon
      • Cannes, France
        • Ch Cannes
      • Chambery, France
        • CH Chambery
      • Clermont Ferrand, France
        • CHU
      • Dijon, France
        • CHU
      • Grasse, France
        • CH Grasse
      • Lyon, France
        • CHU Lyon
      • Lyon, France
        • Chu Edouard Herriot
      • Lyon, France
        • CHU Pierre Benite
      • Nantes, France
        • CH Nantes
      • Nimes, France
        • Chu Nimes
      • Saint Jean de Maurienne, France
        • CH Saint Jean de Maurienne
      • Sallanches, France
        • Hopitaux Du Pays Du Mont Blanc
      • St Julien En Genevois, France
        • Ch Saint Julien En Genevois
      • Thonon Les Bains, France
        • Ch Thonon Les Bains
      • Valence, France
        • CH Valence
      • Voiron, France
        • CH Voiron
    • Isere
      • Grenoble, Isere, France, 38043
        • Chu Grenoble
    • Rhone Alpes
      • Annecy, Rhone Alpes, France, 74000
        • Chra Annecy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within the first week after the injury

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within the first week after trauma
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
neurological outcome on D7 and D28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

CIC Clinical Investigation Centre Grenoble

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 7, 2011

First Submitted That Met QC Criteria

February 7, 2011

First Posted (Estimate)

February 8, 2011

Study Record Updates

Last Update Posted (Estimate)

April 28, 2014

Last Update Submitted That Met QC Criteria

April 25, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC 10 17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Traumatic Brain Injury

Clinical Trials on Transcranial Doppler

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe