Clinical trial NCT03989999: Transcranial Ultrasonography for the Management of Patients With Mild TBI
Official title: Transcranial Ultrasonography for the Management of Patients With Mild Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mild Traumatic Brain Injury
Keywords: Transcranial Doppler
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multicenter, open, non-inferiority, randomized, controlled, study with blinded evaluation.
Primary purpose: PREVENTION

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.

Eligibility 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 anticoagulants or anti-platelet therapy
  * 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.

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

Primary outcomes:
measure: Non-inferiority of a TCD-based strategy after a mild TBI to the standard management in terms of the overall neurological outcome
timeFrame: 3 months after TBI
Secondary outcomes:
measure: Effects of a TCD-based strategy after a mild TBI on the overall neurological outcome
timeFrame: 1 month after TBI
measure: Effects of a TCD-based strategy after a mild TBI on the quality of life
timeFrame: 1 months after TBI
measure: Effects of a TCD-based strategy after a mild TBI on the quality of life
timeFrame: 3 months after TBI
measure: Effects of a TCD-based strategy after a mild TBI on Post-concussive syndrome
timeFrame: 1 month after TBI
measure: Effects of a TCD-based strategy after a mild TBI on Post-concussive syndrome
timeFrame: 3 months after TBI
measure: Effects of a TCD-based strategy after a mild TBI on mortality after TBI
timeFrame: 3 months after TBI
measure: Effects of a TCD-based strategy after a mild TBI on Morbidity after TBI
timeFrame: 1 months after TBI
measure: Effects of a TCD-based strategy after a mild TBI on Morbidity after TBI
timeFrame: 1 months after TBI
measure: Effects of a TCD-based strategy after a mild TBI on patient safety
timeFrame: 1 months after TBI
measure: Effects of a TCD-based strategy after a mild TBI on patient safety
timeFrame: 3 months after TBI
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Lyon
country: France
facility: HCL - Edouard Herriot
city: Lyon
country: France
facility: HCL - Lyon Sud
city: Melun
country: France
facility: CH Melun
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: AP-HP Lariboisière
city: Paris
country: France
facility: AP-HP Pitié Salpetrière
city: Poitiers
country: France
facility: CHU Poitiers
city: Saint Pierre
country: France
facility: Chu Reunion
city: Saint-Denis
country: France
facility: CHU Réunion
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: University Hospital, Grenoble
name: Pierre BOUZAT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.