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ACTIVE NOT RECRUITING
NCT03989999
NA

Transcranial Ultrasonography for the Management of Patients With Mild TBI

Sponsor: University Hospital, Grenoble

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

550

Start Date

2020-02-01

Completion Date

2026-08

Last Updated

2026-03-03

Healthy Volunteers

No

Interventions

PROCEDURE

Transcranial Doppler (TCD)

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 12 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.

Locations (12)

CHU Clermont-Ferrand

Clermont-Ferrand, France

CHU Grenoble Alpes

Grenoble, France

HCL - Edouard Herriot

Lyon, France

HCL - Lyon Sud

Lyon, France

CH Melun

Melun, France

CHU Nantes

Nantes, France

AP-HP Lariboisière

Paris, France

AP-HP Pitié Salpetrière

Paris, France

CHU Poitiers

Poitiers, France

CHU Réunion

Saint-Denis, France

Chu Reunion

Saint-Pierre, France

CHU Toulouse

Toulouse, France