We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Transcranial Ultrasonography for the Management of Patients With Mild TBI (TRUST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03989999
Recruitment Status : Recruiting
First Posted : June 18, 2019
Last Update Posted : November 8, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Mild Traumatic Brain Injury Procedure: Transcranial Doppler (TCD) Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 984 participants
Allocation: Randomized
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.
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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)

  5. 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)

  6. 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

  7. 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

  8. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Pierre BOUZAT, MD, PhD +33 (0)4 76 76 67 29 pbouzat@chu-grenoble.fr
Contact: Anaïs ADOLLE +33 (0)4 76 76 67 29 arcpar@chu-grenoble.fr

Locations
Show Show 19 study locations
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Layout table for investigator information
Principal Investigator: Pierre BOUZAT, MD, PhD University Hospital, Grenoble
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Layout table for additonal information
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03989999    
Other Study ID Numbers: 38RC19.106
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
Transcranial Doppler
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating