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出境医 / 临床实验 / Transcranial Ultrasonography for the Management of Patients With Mild TBI (TRUST)

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

Study Description
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
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 2022
Estimated Study Completion Date : July 2022
Arms and Interventions
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
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
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

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
Tracking Information
First Submitted Date  ICMJE June 14, 2019
First Posted Date  ICMJE June 18, 2019
Last Update Posted Date April 9, 2021
Actual Study Start Date  ICMJE February 1, 2020
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcranial Ultrasonography for the Management of Patients With Mild TBI
Official Title  ICMJE Transcranial Ultrasonography for the Management of Patients With Mild Traumatic Brain Injury
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Mild Traumatic Brain Injury
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: TCD Group
    Transcranial Doppler within 8 hours of traumatic injury
    Intervention: Procedure: Transcranial Doppler (TCD)
  • No Intervention: CONTROL Group
    Mild TBI management with SFMU recommandations
Publications *
  • Maas AIR, Menon DK, Adelson PD, Andelic N, Bell MJ, Belli A, Bragge P, Brazinova A, Büki 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, Söderberg J, Stanworth SJ, Stein MB, von Steinbüchel 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. Review.
  • 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. Review.
  • 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.
  • 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 14, 2019) 		984
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE France,   Monaco
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03989999
Other Study ID Numbers  ICMJE 38RC19.106
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Grenoble
Study Sponsor  ICMJE University Hospital, Grenoble
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pierre BOUZAT, MD, PhD University Hospital, Grenoble
PRS Account University Hospital, Grenoble
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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