Traumatic Brain Injury
Conditions
Keywords
Transcranial Doppler, Mild and moderate Traumatic Brain Injury, Neurological deterioration, Brain CT scan
Brief 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. 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.
Interventions
DEVICETranscranial Doppler
Negative predictive value of transcranial doppler in patients with mild to moderate traumatic brain injury
Sponsors
CIC Clinical Investigation Centre Grenoble
University Hospital, Grenoble
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Negative predictive value of transcranial doppler | 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
| Measure | Time frame | Description |
|---|---|---|
| the impact of transcranial doppler for initial patient management | 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. |
| Secondary neurological aggravation: risk factors and consequences. | 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 |
Countries
France
Outcome results
None listed