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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Multicentre, Observational Study

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Device: Transcranial Doppler


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mild TBI with mild lesions on CT scan<br>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<br>* Negative predictive value of transcranial doppler in patients with mild to moderate traumatic brain injury<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative predictive value of transcranial doppler | 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 | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial Doppler, Mild and moderate Traumatic Brain Injury, Neurological deterioration, Brain CT scan