Mild Traumatic Brain InjuryTRUSTNCT03989999
Transcranial Ultrasonography for the Management of Patients With Mild TBI
A study testing Transcranial Doppler (TCD) in people with Mild Traumatic Brain Injury, run by University Hospital, Grenoble at 12 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- Transcranial Doppler (TCD)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 12 sitesFrance
- Study dates
- 1 Feb 2020to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
CHU Clermont-Ferrand
Clermont-Ferrand
CHU Grenoble Alpes
Grenoble
HCL - Edouard Herriot
Lyon
HCL - Lyon Sud
Lyon
CH Melun
Melun
CHU Nantes
Nantes
AP-HP Lariboisière
Paris
AP-HP Pitié Salpetrière
Paris
CHU Poitiers
Poitiers
CHU Réunion
Saint-Denis, 97400
Chu Reunion
Saint-Pierre, 97448
CHU Toulouse
Toulouse
About this study
Official title: Transcranial Ultrasonography for the Management of Patients With Mild Traumatic Brain Injury
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.
Read the 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
- Being tested
- Transcranial Doppler (TCD)
- Keywords
- Transcranial Doppler
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Doppler (TCD)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| TCD Group | Experimental | Transcranial Doppler within 12 hours of traumatic injury Receives: Procedure: Transcranial Doppler (TCD) |
| CONTROL Group | No intervention | Mild TBI management with SFMU recommandations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after TBI
Secondary outcomes (10)
Effects of a TCD-based strategy after a mild TBI on the overall neurological outcome
GOS-Extended. Evaluation is centralized and blinded.
Measured: 1 month after TBI
Effects of a TCD-based strategy after a mild TBI on the quality of life
Questionnaires QOLIBRI (Quality of life after TBI) and EQ-5D-5L
Measured: 1 months after TBI
Effects of a TCD-based strategy after a mild TBI on the quality of life
Questionnaires QOLIBRI (Quality of life after TBI) and EQ-5D-5L
Measured: 3 months after TBI
Effects of a TCD-based strategy after a mild TBI on Post-concussive syndrome
Rivermead Post-Concussion Symptoms questionnaire at 1 month and 3 months after TBI ("Rivermead positive" patients are patients with at least 3 symptoms rated ≥ 2)
Measured: 1 month after TBI
Effects of a TCD-based strategy after a mild TBI on Post-concussive syndrome
Rivermead Post-Concussion Symptoms questionnaire at 1 month and 3 months after TBI ("Rivermead positive" patients are patients with at least 3 symptoms rated ≥ 2)
Measured: 3 months after TBI
Effects of a TCD-based strategy after a mild TBI on mortality after TBI
Mortality within the first 3 months
Measured: 3 months after TBI
Effects of a TCD-based strategy after a mild TBI on Morbidity after TBI
Number of cerebral CT scans within the hospital stay, • Thromboembolic events or diagnosed nosocomial infections stay
Measured: 1 months after TBI
Effects of a TCD-based strategy after a mild TBI on Morbidity after TBI
Length of hospital stay ; Length of ICU stay
Measured: 1 months after TBI
Effects of a TCD-based strategy after a mild TBI on patient safety
Number of patients re-admitted to hospital in relation with the initial TBI
Measured: 1 months after TBI
Effects of a TCD-based strategy after a mild TBI on patient safety
Number of patients with neurologic worsening within the first week after TBI.
Measured: 7 days after TBI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start1 Feb 2020
- Primary completion31 Aug 2025
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, open, non-inferiority, randomized, controlled, study with blinded evaluation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre BOUZAT, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989999
- Sponsor's protocol ID
- 38RC19.106
- Acronym
- TRUST
- Status last verified
- Oct 2026
- First submitted
- 14 Jun 2019
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29122524Tagliaferri 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.
PubMed 16311842Davis 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.
PubMed 17297312af 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.
PubMed 15662058Bouzat 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.
PubMed 41024218
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Ultrasonography for the Management of Patients With Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03989999
- Acronym / sponsor ID
- TRUST / 38RC19.106
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- Transcranial Doppler
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 18 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, multicenter, open, non-inferiority, randomized, controlled, study with blinded evaluation.
| Arm | Type | Receives |
|---|---|---|
| TCD Group | Experimental | Procedure: Transcranial Doppler (TCD)Transcranial Doppler within 12 hours of traumatic injury |
| CONTROL Group | No intervention | –Mild TBI management with SFMU recommandations |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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 :
- Possibility of home supervision by a third-party
- Affiliation to the French social security system
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | TCD Group |
Primary outcome
Non-inferiority of a TCD-based strategy after a mild TBI to the standard management in terms of the overall neurological outcome
Time frame: 3 months after TBI
GOS-E will be dichotomized as complete recovery (GOS-E 8) vs. incomplete recovery (GOS-E 1 to 7). Evaluation is centralized and blinded.
10 secondary outcomes
Effects of a TCD-based strategy after a mild TBI on the overall neurological outcome
Time frame: 1 month after TBI
Effects of a TCD-based strategy after a mild TBI on the quality of life
Time frame: 1 months after TBI
Effects of a TCD-based strategy after a mild TBI on the quality of life
Time frame: 3 months after TBI
Effects of a TCD-based strategy after a mild TBI on Post-concussive syndrome
Time frame: 1 month after TBI
Effects of a TCD-based strategy after a mild TBI on Post-concussive syndrome
Time frame: 3 months after TBI
Effects of a TCD-based strategy after a mild TBI on mortality after TBI
Time frame: 3 months after TBI
Effects of a TCD-based strategy after a mild TBI on Morbidity after TBI
Time frame: 1 months after TBI
Effects of a TCD-based strategy after a mild TBI on Morbidity after TBI
Time frame: 1 months after TBI
Effects of a TCD-based strategy after a mild TBI on patient safety
Time frame: 1 months after TBI
Effects of a TCD-based strategy after a mild TBI on patient safety
Time frame: 7 days after TBI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Background: PubMed 29122524Maas 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.
- Background: PubMed 16311842Tagliaferri 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.
- Background: PubMed 17297312Davis 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.
- Background: PubMed 15662058af 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.
- Background: PubMed 41024218Bouzat 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre BOUZAT, MD, PhD principal investigator
University Hospital, Grenoble
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Doppler (TCD) in people with Mild Traumatic Brain Injury, run by University Hospital, Grenoble at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority of a TCD-based strategy after a mild TBI to the standard management in terms of the overall neurological outcome (time frame: 3 months after TBI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03989999, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.