- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03989999
Transcranial Ultrasonography for the Management of Patients With Mild TBI (TRUST)
Transcranial Ultrasonography for the Management of Patients With Mild Traumatic Brain Injury
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pierre BOUZAT, MD, PhD
- Phone Number: +33 (0)4 76 76 67 29
- Email: pbouzat@chu-grenoble.fr
Study Contact Backup
- Name: Anaïs ADOLLE
- Phone Number: +33 (0)4 76 76 67 29
- Email: arcpar@chu-grenoble.fr
Study Locations
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Bourg-en-Bresse, France
- Withdrawn
- CH Bourg-en-Bresse
-
Clermont-Ferrand, France
- Recruiting
- CHU Clermont-Ferrand
-
Principal Investigator:
- Christophe PERRIER, MD
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Grenoble, France
- Recruiting
- Chu Grenoble Alpes
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Principal Investigator:
- DAMIEN VIGLINO, MD
-
Sub-Investigator:
- Maxime MAIGNAN, MD
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Lille, France
- Recruiting
- CHRU Lille
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Principal Investigator:
- Delphine GARRIGUE, MD
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Lyon, France
- Recruiting
- HCL - Edouard Herriot
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Principal Investigator:
- Karim TAZAROURTE, MD, PhD
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Lyon, France
- Not yet recruiting
- HCL - Lyon Sud
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Principal Investigator:
- Marion DOUPLAT, MD
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Marseille, France
- Withdrawn
- AP-HM Timone
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Melun, France
- Recruiting
- CH Melun
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Principal Investigator:
- David SAPIR, MD
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Montpellier, France
- Not yet recruiting
- CHRU Montpellier
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Principal Investigator:
- Mustapha SEBBANE, MD, PhD
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Nantes, France
- Recruiting
- CHU Nantes
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Principal Investigator:
- Philippe PES, MD
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Nîmes, France
- Withdrawn
- CHU Nimes
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Paris, France
- Recruiting
- AP-HP Lariboisiere
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Principal Investigator:
- Anthony CHAUVIN, MD
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Paris, France
- Recruiting
- AP-HP Pitié Salpetrière
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Principal Investigator:
- Martha Cancella de Abreu, MD, PhD
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Paris, France
- Not yet recruiting
- AP-HP - Avicenne
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Principal Investigator:
- Aurélien GUENIN, MD
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Poitiers, France
- Recruiting
- CHU Poitiers
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Principal Investigator:
- Jeremy GUENEZAN, MD
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Saint Pierre, France, 97448
- Recruiting
- CHU Réunion
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Principal Investigator:
- Nathalia EBRAN, MD
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Sub-Investigator:
- ADRIEN VAGUE, MD
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Saint-Denis, France, 97400
- Recruiting
- CHU Réunion
-
Principal Investigator:
- Bertrand GUIHARD, MD
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Toulouse, France
- Recruiting
- CHU Toulouse
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Principal Investigator:
- Charles Henri Houzé-Cerfon, MD
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-
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Monaco, Monaco
- Recruiting
- CH Monaco
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Principal Investigator:
- Yann-Erick CLAESSENS, MD, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TCD Group
Transcranial Doppler within 8 hours of traumatic injury
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months after TBI
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
|
Questionnaires QOLIBRI (Quality of life after TBI) and EQ-5D-5L
|
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
|
Questionnaires QOLIBRI (Quality of life after TBI) and EQ-5D-5L
|
3 months after TBI
|
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)
|
1 month after TBI
|
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)
|
3 months after TBI
|
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
|
1 months after TBI
|
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
|
3 months after TBI
|
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.
|
3 months after TBI
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pierre BOUZAT, MD, PhD, University Hospital, Grenoble
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC19.106
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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