Active — Not RecruitingNot Applicable

Transcranial Ultrasonography for the Management of Patients With Mild TBI

France550 participantsStarted 2020-02-01

Plain-language summary

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.

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 anticoagulants or anti-platelet therapy * 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 12 hours * Stable hemodynamics defined as a blood pressure greater than 90 mmHg, an SpO2 greater than 92% and a hemoglobin concentration greater than 8g/dl, or, in the absence of measured physiologic parameters or the absence of biological sampling, mention in the patient's medical record of a stable clinical examination in terms of hemodynamics and respiratory function. 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 hemostasi…

What they're measuring

Non-inferiority of a TCD-based strategy after a mild TBI to the standard management in terms of the overall neurological outcome

Timeframe: 3 months after TBI

Trial details

NCT IDNCT03989999

SponsorUniversity Hospital, Grenoble

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-31