Transcranial Ultrasonography for the Management of Patients With Mild Traumatic Brain Injury

Transcranial Ultrasonography for the Management of Patients With Mild TBI

Sponsors

Lead sponsor: University Hospital, Grenoble

Source University Hospital, Grenoble
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.

Overall Status Recruiting
Start Date December 10, 2019
Completion Date June 2022
Primary Completion Date March 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Non-inferiority of a TCD-based strategy after a mild TBI to the standard management in terms of the overall neurological outcome 3 months after TBI
Secondary Outcome
Measure Time Frame
Effects of a TCD-based strategy after a mild TBI on the overall neurological outcome 1 month after TBI
Effects of a TCD-based strategy after a mild TBI on the quality of life 1 months after TBI
Effects of a TCD-based strategy after a mild TBI on the quality of life 3 months after TBI
Effects of a TCD-based strategy after a mild TBI on Post-concussive syndrome 1 month after TBI
Effects of a TCD-based strategy after a mild TBI on Post-concussive syndrome 3 months after TBI
Effects of a TCD-based strategy after a mild TBI on Morbidity after TBI 1 months after TBI
Effects of a TCD-based strategy after a mild TBI on mortality after TBI 3 months after TBI
Effects of a TCD-based strategy after a mild TBI on patient safety 3 months after TBI
Enrollment 984
Condition
Intervention

Intervention type: Procedure

Intervention name: Transcranial Doppler (TCD)

Description: 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.

Arm group label: TCD Group

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 aspirin

- and /or persisting nausea, and/or vomiting and/or headaches

- 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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Pierre BOUZAT, MD, PhD Principal Investigator University Hospital, Grenoble
Overall Contact

Last name: Pierre BOUZAT, MD, PhD

Phone: +33 (0)4 76 76 67 29

Email: [email protected]

Location
facility status investigator
CH Bourg-en-bresse | Bourg-en-Bresse, France Recruiting Patrice SERRE, MD Principal Investigator
CHU Clermont-Ferrand | Clermont-Ferrand, France Not yet recruiting Christophe PERRIER, MD Principal Investigator
CHU Grenoble Alpes | Grenoble, France Recruiting Maxime MAIGNAN, MD Principal Investigator
CHRU Lille | Lille, France Not yet recruiting Delphine GARRIGUE, MD Principal Investigator
HCL - Edouard Herriot | Lyon, France Not yet recruiting Karim TAZAROURTE, MD, PhD Principal Investigator
HCL - Lyon Sud | Lyon, France Not yet recruiting Marion DOUPLAT, MD Principal Investigator
AP-HM Timone | Marseille, France Not yet recruiting Pierre MICHELET, MD, PhD Principal Investigator
CH Melun | Melun, France Not yet recruiting David SAPIR, MD Principal Investigator
CHRU Montpellier | Montpellier, France Not yet recruiting Mustapha SEBBANE, MD, PhD Principal Investigator
CHU Nantes | Nantes, France Recruiting Philippe PES, MD Principal Investigator
CHU Nîmes | Nîmes, France Not yet recruiting Xavier BOBBIA, MD Principal Investigator
AP-HP - Avicenne | Paris, France Not yet recruiting Aurélien GUENIN, MD Principal Investigator
AP-HP Lariboisière | Paris, France Not yet recruiting Anthony CHAUVIN, MD Principal Investigator
AP-HP Pitié Salpetrière | Paris, France Not yet recruiting Martha Cancella de Abreu, MD, PhD Principal Investigator
CHU Poitiers | Poitiers, France Not yet recruiting Jeremy GUENEZAN, MD Principal Investigator
CHU Réunion | Saint-Denis, 97400, France Not yet recruiting Bertrand GUIARD, MD Principal Investigator
CHU Toulouse | Toulouse, France Not yet recruiting Frédéric BALEN, MD Principal Investigator
CH Monaco | Monaco, Monaco Not yet recruiting Yann-Erick CLAESSENS, MD, PhD Principal Investigator
Location Countries

France

Monaco

Verification Date

February 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: TCD Group

Arm group type: Experimental

Description: Transcranial Doppler within 8 hours of traumatic injury

Arm group label: CONTROL Group

Arm group type: No Intervention

Description: Mild TBI management with SFMU recommandations

Acronym TRUST
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Prospective, multicenter, open, non-inferiority, randomized, controlled, study with blinded evaluation.

Primary purpose: Prevention

Masking: Single (Outcomes Assessor)

Masking description: The evaluation at 3 months after TBI will be centralized by the coordinating centre and blinded.

Source: ClinicalTrials.gov