Transcranial Ultrasonography for the Management of Patients With Mild TBI

Study Overview
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Brief Summary
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The investigators hypothesize that patients with mild TBI and normal TCD can be safely discharged home immediately after the ED. The targeted population is the category of patients eligible for early discharge: 1) patients with mild lesions on the initial CT scan and a GCS 15 after CT scan completion and, 2) patients with no lesion on the initial cerebral CT scan with at least one of the following risk factors: GCS 14 after CT scan completion, persisting post-traumatic nausea/vomiting/headaches, concomitant alcoholic intoxication or patients treated with aspirin. The study will not include mild TBI patients who are not eligible for early discharge: patients with no possibility of home supervision, those with a GCS lower than 14 after the CT scan or those treated with anticoagulant/antiplatelet drugs other than aspirin. The investigators expect the TCD-based strategy to be non-inferior compared to the standard strategy according to French recommendations in terms of the 3-months neurological outcome. From a public health standpoint, the use of TCD as a triage tool may change current guidelines regarding mild TBI management.

Detailed Description
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Patients with mild traumatic brain injury (TBI) represent the vast majority of TBI patients admitted in the emergency department (ED). According to French recommendations, mild TBI patients with brain lesions on initial CT scan are directed to a standard ward, where neurologic monitoring consists of repeated CT scanning and clinical exams. Patients with no lesion on initial cerebral CT scan are also hospitalized 1) when their GCS after CT scan is lower than 15, 2) in case of persisting nausea, vomiting or headache, 3) in case of concomitant alcoholic intoxication and, 4) in case of on-going treatment with aspirin. This strategy induces significant hospital stay with potential morbidity, whereas neurologic worsening rarely occurs. In this context, the implementation of a triage tool in the ED would be useful to screen patients at risk of early neurologic worsening. Hence, low risk patients may be discharged at home immediately after the ED. Transcranial Doppler (TCD) is a non-invasive technique that measures cerebral blood flow velocities in intracranial cerebral arteries. These velocities and a derivated parameter (pulsatility index, PI), estimate cerebral blood flow (CBF) and have become a standard of care to optimize CBF in after severe TBI. Only few studies report the use of TCD after mild TBI. In a single-center cohort of patients with mild-to-moderate TBI, TCD parameters measured at hospital admission accurately predicted early neurologic worsening. These encouraging results indicate that TCD, in combination with CT scan findings, could play a role in the management of patients with mild TBI. The aim of this project is to determine whether a TCD-based strategy is non-inferior to the standard management in terms of the overall neurological outcome at 3 months after mild TBI with no/minor lesions detected on a cerebral CT scan.

Official Title
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Transcranial Ultrasonography for the Management of Patients With Mild Traumatic Brain Injury

Conditions
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Mild Traumatic Brain Injury

Intervention / Treatment
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* Procedure: Transcranial Doppler (TCD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild TBI (GCS 13-15 on ED admission) with one of the following: Patient with minor cerebral lesion on initial CT scan (TCDBII i.e. no midline shift, visible basal cisterns and haemorrhagic lesion < 25 cc) and GCS 15 after CT scan OR * Patient with normal initial CT scan (TCDB I) with at least one risk factor : GCS = 14 after CT scan and/or alcoholic intoxication and/or on-going treatment with aspirin and /or persisting nausea, and/or vomiting and/or headaches Early initial CT scan (< 4 hours after TBI) Possibility of home supervision by a third-party Affiliation to the French social security system Patient have signed consent form Possibility to perform a TCD within 8 hours Stable hemodynamics: systolic blood pressure >90 mmHg, peripheral capillary oxygen saturation >92%, hemoglobin > 8 g/dl Exclusion Criteria: CT scan classified as TCDB III - VI Penetrating head-trauma Patient under mechanical ventilation Patients treated with anticoagulants or anti-platelet therapy (except Aspirin) Hospitalization required by post-traumatic extra-cranial lesion, intoxication (except alcoholic), pre-existing condition (including congenital hemostasis disorders) or social factors at the discretion of the physician. Internal Carotid dissection Post-traumatic lesion in the posterior cerebral fossa Subject in exclusion period of another interventional study, Pregnant women, breastfeeding women Subject under administrative or judicial control, under protection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, multicenter, open, non-inferiority, randomized, controlled, study with blinded evaluation.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TCD Group<br>Transcranial Doppler within 8 hours of traumatic injury | Procedure: Transcranial Doppler (TCD)<br>* In the Emergency Department (ED): After the initial cerebral CT scan, the patient will be included in the study when he/she satisfies inclusion criteria. TCD will be performed within 8 hours of the brain injury. If TCD is normal (FVd>25 cm/sec and PI <1.25), the patient will return home under third-party supervision. An advice sheet will be given to the patient according to the SFMU guidelines and another one will be sent to the general practitioner. If initial cerebral CT scan is performed early (< 4-6 hours after TBI), CT scan should not be controlled before patient discharge. If the TCD is abnormal (FVd≤25 cm/sec or PI ≥ 1.25) the patient will be hospitalized. There is no recommendation regarding the type of hospitalization (ICU or standard ward). No other diagnostic procedure is allowed in the ED (S-100 protein dosing is not allowed). All therapies recommended by the SFMU for mild TBI are allowed in this group.<br>|
| No Intervention: CONTROL Group<br>Mild TBI management with SFMU recommandations | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-inferiority of a TCD-based strategy after a mild TBI to the standard management in terms of the overall neurological outcome | GOS-E will be dichotomized as good recovery (GOS-E 7 or 8) vs. disability (GOS-E 1 to 6). Evaluation is centralized and blinded. | 3 months after TBI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of a TCD-based strategy after a mild TBI on the overall neurological outcome | GOS-E will be dichotomized as good recovery (GOS-E 7 or 8) vs. disability (GOS-E 1 to 6). Evaluation is centralized and blinded. | 1 month after TBI | 
| Effects of a TCD-based strategy after a mild TBI on the quality of life | Questionnaires QOLIBRI (Quality of life after TBI) and EQ-5D-5L | 1 months after TBI | 
| Effects of a TCD-based strategy after a mild TBI on the quality of life | Questionnaires QOLIBRI (Quality of life after TBI) and EQ-5D-5L | 3 months after TBI | 
| Effects of a TCD-based strategy after a mild TBI on Post-concussive syndrome | Rivermead Post-Concussion Symptoms questionnaire at 1 month and 3 months after TBI (Rivermead positive patients are patients with at least 3 symptoms rated ≥ 2) | 1 month after TBI | 
| Effects of a TCD-based strategy after a mild TBI on Post-concussive syndrome | Rivermead Post-Concussion Symptoms questionnaire at 1 month and 3 months after TBI (Rivermead positive patients are patients with at least 3 symptoms rated ≥ 2) | 3 months after TBI | 
| Effects of a TCD-based strategy after a mild TBI on Morbidity after TBI | Number of cerebral CT scans within the hospital stay, • Thromboembolic events or diagnosed nosocomial infections stay | 1 months after TBI | 
| Effects of a TCD-based strategy after a mild TBI on mortality after TBI | Mortality within the first 3 months | 3 months after TBI | 
| Effects of a TCD-based strategy after a mild TBI on patient safety | Number of patients with neurologic worsening within the first week after TBI. | 3 months after TBI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial Doppler