Informations générales (source: ClinicalTrials.gov)
Transcranial Ultrasonography for the Management of Patients With Mild Traumatic Brain Injury (TRUST)
Interventional
N/A
University Hospital, Grenoble (Voir sur ClinicalTrials)
février 2020
août 2026
30 avril 2025
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HM Timone - Marseille - France | Contact (sur clinicalTrials) | ||||
| CHU Clermont-Ferrand - Clermont-Ferrand - France | Christophe PERRIER, MD | Contact (sur clinicalTrials) | |||
| CHU Grenoble Alpes - Grenoble - France | Maxime MAIGNAN, MD | Contact (sur clinicalTrials) | |||
| CHU Poitiers - Poitiers - France | Jeremy GUENEZAN, MD | Contact (sur clinicalTrials) | |||
| CHU Réunion - 97400 - Saint-Denis - France | Bertrand GUIHARD, MD | Contact (sur clinicalTrials) | |||
| CHU Toulouse - Toulouse - France | Charles Henri Houzé-Cerfon, MD | Contact (sur clinicalTrials) | |||
| HCL - Edouard Herriot - Lyon - France | Karim TAZAROURTE, MD, PhD | Contact (sur clinicalTrials) | |||
| HCL - Lyon Sud - Lyon - France | Marion DOUPLAT, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP Lariboisière - Paris - France | Anthony CHAUVIN, MD | Contact (sur clinicalTrials) | |||
| AP-HP Pitié Salpetrière - Paris - France | Martha Cancella de Abreu, MD, PhD | Contact (sur clinicalTrials) | |||
| CH Bourg-en-bresse - Bourg-en-Bresse - France | Contact (sur clinicalTrials) | ||||
| CH Melun - Melun - France | David SAPIR, MD | Contact (sur clinicalTrials) | |||
| CHRU Lille - Lille - France | Delphine GARRIGUE, MD | Contact (sur clinicalTrials) | |||
| CHU Nantes - Nantes - France | Philippe PES, MD | Contact (sur clinicalTrials) | |||
| Chu Reunion - 97448 - Saint Pierre - France | Nathalia EBRAN, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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