Using Transcranial Ultrasonography to Manage Mild Traumatic Brain Injury

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

This study tests if using a special ultrasound can help doctors decide if patients with mild brain injuries can safely go home instead of staying in the hospital.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 550 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: University Hospital, Grenoble (Academic / other)
• Locations: 16 sites (Bourg-en-Bresse and 15 other locations)
• Trial ID: NCT03989999 on ClinicalTrials.gov

What this trial studies

This study investigates the use of Transcranial Doppler (TCD) to assess patients with mild traumatic brain injury (TBI) in the emergency department. The goal is to determine if patients with mild TBI and normal TCD results can be safely discharged home immediately, rather than being hospitalized for monitoring. The study focuses on patients with specific criteria, including those with minor lesions or normal CT scans and certain risk factors. By implementing this non-invasive technique, the researchers aim to reduce unnecessary hospital stays while ensuring patient safety.

Who should consider this trial

Good fit: Ideal candidates are patients with mild TBI (GCS 13-15) who meet specific criteria for early discharge.

Not a fit: Patients with severe TBI, those requiring close monitoring, or those with contraindications for discharge will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could allow for safer and quicker discharges for patients with mild TBI, reducing hospital stays and associated costs.

How similar studies have performed: While few studies have explored TCD in mild TBI, existing research suggests promising outcomes, indicating potential for success in this approach.

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

Where this trial is running

Bourg-en-Bresse and 15 other locations

• CH Bourg-en-bresse — Bourg-en-Bresse, France (Withdrawn)
• CHU Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
• CHU Grenoble Alpes — Grenoble, France (Recruiting)
• CHRU Lille — Lille, France (Recruiting)
• HCL - Edouard Herriot — Lyon, France (Recruiting)
• HCL - Lyon Sud — Lyon, France (Not_yet_recruiting)
• AP-HM Timone — Marseille, France (Withdrawn)
• CH Melun — Melun, France (Recruiting)
• CHU Nantes — Nantes, France (Recruiting)
• AP-HP Lariboisière — Paris, France (Recruiting)
• AP-HP Pitié Salpetrière — Paris, France (Recruiting)
• CHU Poitiers — Poitiers, France (Recruiting)
• Chu Reunion — Saint Pierre, France (Recruiting)
• CHU Réunion — Saint-Denis, France (Recruiting)
• CHU Toulouse — Toulouse, France (Recruiting)
• CH Monaco — Monaco, Monaco (Recruiting)

Study contacts

• Principal investigator: Pierre BOUZAT, MD, PhD — University Hospital, Grenoble
• Study coordinator: Pierre BOUZAT, MD, PhD

Conditions Mild Traumatic Brain Injury; Transcranial Doppler