Transcranial Ultrasonography for the Management of Patients With Mild TBI

NCT03989999 | Active Not Recruiting DMC

• 1 other identifier: 38RC19.106
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Mild Traumatic Brain Injury

Keywords

Transcranial Doppler

Outcome Measures

Primary Outcomes (1)

• 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 complete recovery (GOS-E 8) vs. incomplete recovery (GOS-E 1 to 7). Evaluation is centralized and blinded.

  3 months after TBI

Secondary Outcomes (10)

• Effects of a TCD-based strategy after a mild TBI on the overall neurological outcome

  1 month after TBI

• Effects of a TCD-based strategy after a mild TBI on the quality of life

  1 months after TBI

• Effects of a TCD-based strategy after a mild TBI on the quality of life

  3 months after TBI

• Effects of a TCD-based strategy after a mild TBI on Post-concussive syndrome

  1 month after TBI

• Effects of a TCD-based strategy after a mild TBI on Post-concussive syndrome

  3 months after TBI

Study Arms (2)

TCD Group

EXPERIMENTAL

Transcranial Doppler within 12 hours of traumatic injury

Procedure: Transcranial Doppler (TCD)

CONTROL Group

NO INTERVENTION

Mild TBI management with SFMU recommandations

Interventions

Transcranial Doppler (TCD) PROCEDURE

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.

TCD Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Pregnant women, breastfeeding women
• Subject under administrative or judicial control, under protection

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (12)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

CHU Grenoble Alpes

Grenoble, France

Location

HCL - Edouard Herriot

Lyon, France

Location

HCL - Lyon Sud

Lyon, France

Location

CH Melun

Melun, France

Location

CHU Nantes

Nantes, France

Location

AP-HP Lariboisière

Paris, France

Location

AP-HP Pitié Salpetrière

Paris, France

Location

CHU Poitiers

Poitiers, France

Location

CHU Réunion

Saint-Denis, 97400, France

Location

Chu Reunion

Saint-Pierre, 97448, France

Location

CHU Toulouse

Toulouse, France

Location

Related Publications (5)

• Maas AIR, Menon DK, Adelson PD, Andelic N, Bell MJ, Belli A, Bragge P, Brazinova A, Buki A, Chesnut RM, Citerio G, Coburn M, Cooper DJ, Crowder AT, Czeiter E, Czosnyka M, Diaz-Arrastia R, Dreier JP, Duhaime AC, Ercole A, van Essen TA, Feigin VL, Gao G, Giacino J, Gonzalez-Lara LE, Gruen RL, Gupta D, Hartings JA, Hill S, Jiang JY, Ketharanathan N, Kompanje EJO, Lanyon L, Laureys S, Lecky F, Levin H, Lingsma HF, Maegele M, Majdan M, Manley G, Marsteller J, Mascia L, McFadyen C, Mondello S, Newcombe V, Palotie A, Parizel PM, Peul W, Piercy J, Polinder S, Puybasset L, Rasmussen TE, Rossaint R, Smielewski P, Soderberg J, Stanworth SJ, Stein MB, von Steinbuchel N, Stewart W, Steyerberg EW, Stocchetti N, Synnot A, Te Ao B, Tenovuo O, Theadom A, Tibboel D, Videtta W, Wang KKW, Williams WH, Wilson L, Yaffe K; InTBIR Participants and Investigators. Traumatic brain injury: integrated approaches to improve prevention, clinical care, and research. Lancet Neurol. 2017 Dec;16(12):987-1048. doi: 10.1016/S1474-4422(17)30371-X. Epub 2017 Nov 6. No abstract available.

  PMID: 29122524 BACKGROUND

• Tagliaferri F, Compagnone C, Korsic M, Servadei F, Kraus J. A systematic review of brain injury epidemiology in Europe. Acta Neurochir (Wien). 2006 Mar;148(3):255-68; discussion 268. doi: 10.1007/s00701-005-0651-y.

  PMID: 16311842 BACKGROUND

• Davis DP, Kene M, Vilke GM, Sise MJ, Kennedy F, Eastman AB, Velky T, Hoyt DB. Head-injured patients who "talk and die": the San Diego perspective. J Trauma. 2007 Feb;62(2):277-81. doi: 10.1097/TA.0b013e31802ef4a3.

  PMID: 17297312 BACKGROUND

• af Geijerstam JL, Britton M. Mild head injury: reliability of early computed tomographic findings in triage for admission. Emerg Med J. 2005 Feb;22(2):103-7. doi: 10.1136/emj.2004.015396.

  PMID: 15662058 BACKGROUND

• Bouzat P, Gauss T, Adolle A, Roustit M, Bosson JL, Tazarourte K. Transcranial Doppler to guide early discharge after mild traumatic brain injury, the TRUST trial: study protocol for an open-label multisite noninferiority randomized controlled trial. Trials. 2025 Sep 29;26(1):371. doi: 10.1186/s13063-025-09086-0.

  PMID: 41024218 BACKGROUND

MeSH Terms

Conditions

Brain Concussion

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Pierre BOUZAT, MD, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluation at 3 months after TBI will be centralized by the coordinating centre and blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, open, non-inferiority, randomized, controlled, study with blinded evaluation.

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 18, 2019
• Study Start: February 1, 2020
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)