Transcranial Ultrasonography for the Management of Patients With Mild TBI

NCT ID: NCT03989999

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 550 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2026-08-31

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.

Detailed Description

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.

Conditions

Mild Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

TCD Group

Transcranial Doppler within 12 hours of traumatic injury

Group Type: EXPERIMENTAL

Transcranial Doppler (TCD)

Intervention Type: 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.

CONTROL Group

Mild TBI management with SFMU recommandations

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre BOUZAT, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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

Countries

France

References

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Reference Type: BACKGROUND

PMID: 29122524 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16311842 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17297312 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15662058 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 41024218 (View on PubMed)

Other Identifiers

38RC19.106

Identifier Type: -

Identifier Source: org_study_id