Transcranial Ultrasonography for the Management of Patients With Mild TBI (TRUST)
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|ClinicalTrials.gov Identifier: NCT03989999|
Recruitment Status : Recruiting
First Posted : June 18, 2019
Last Update Posted : November 8, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Mild Traumatic Brain Injury||Procedure: Transcranial Doppler (TCD)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||984 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective, multicenter, open, non-inferiority, randomized, controlled, study with blinded evaluation.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The evaluation at 3 months after TBI will be centralized by the coordinating centre and blinded.|
|Official Title:||Transcranial Ultrasonography for the Management of Patients With Mild Traumatic Brain Injury|
|Actual Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||July 2023|
Experimental: TCD Group
Transcranial Doppler within 8 hours of traumatic injury
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 8 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.
No Intervention: CONTROL Group
Mild TBI management with SFMU recommandations
- 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 good recovery (GOS-E 7 or 8) vs. disability (GOS-E 1 to 6). Evaluation is centralized and blinded.
- Effects of a TCD-based strategy after a mild TBI on the overall neurological outcome [ Time Frame: 1 month after TBI ]GOS-E will be dichotomized as good recovery (GOS-E 7 or 8) vs. disability (GOS-E 1 to 6). Evaluation is centralized and blinded.
- Effects of a TCD-based strategy after a mild TBI on the quality of life [ Time Frame: 1 months after TBI ]Questionnaires QOLIBRI (Quality of life after TBI) and EQ-5D-5L
- Effects of a TCD-based strategy after a mild TBI on the quality of life [ Time Frame: 3 months after TBI ]Questionnaires QOLIBRI (Quality of life after TBI) and EQ-5D-5L
- Effects of a TCD-based strategy after a mild TBI on Post-concussive syndrome [ Time Frame: 1 month after TBI ]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)
- Effects of a TCD-based strategy after a mild TBI on Post-concussive syndrome [ Time Frame: 3 months after TBI ]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)
- Effects of a TCD-based strategy after a mild TBI on Morbidity after TBI [ Time Frame: 1 months after TBI ]Number of cerebral CT scans within the hospital stay, • Thromboembolic events or diagnosed nosocomial infections stay
- Effects of a TCD-based strategy after a mild TBI on mortality after TBI [ Time Frame: 3 months after TBI ]Mortality within the first 3 months
- Effects of a TCD-based strategy after a mild TBI on patient safety [ Time Frame: 3 months after TBI ]Number of patients with neurologic worsening within the first week after TBI.
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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 aspirin
- 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 8 hours
- Stable hemodynamics: systolic blood pressure >90 mmHg, peripheral capillary oxygen saturation >92%, hemoglobin > 8 g/dl
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03989999
|Contact: Pierre BOUZAT, MD, PhD||+33 (0)4 76 76 67 email@example.com|
|Contact: Anaïs ADOLLE||+33 (0)4 76 76 67 firstname.lastname@example.org|
|Principal Investigator:||Pierre BOUZAT, MD, PhD||University Hospital, Grenoble|
|Responsible Party:||University Hospital, Grenoble|
|Other Study ID Numbers:||
|First Posted:||June 18, 2019 Key Record Dates|
|Last Update Posted:||November 8, 2022|
|Last Verified:||November 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Brain Injuries, Traumatic
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed