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Completed

NCT Number: NCT01291706

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

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRA Annecy, Annecy, Auvergne-Rhône-Alpes, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Doppler

Device

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

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • CIC Clinical Investigation Centre Grenoble

Registry information

Official study title

Prospective, Multicentre, Observational Study

Acronym: TCD

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 8, 2011
Registry last updated
Apr 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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