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Ultrasound may let mild head injury patients skip hospital stay

NCT ID NCT03989999

Knowledge-focused Sponsor: University Hospital, Grenoble Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a simple ultrasound of the brain's blood flow can safely identify mild traumatic brain injury patients who can go home right away instead of staying in the hospital for observation. About 550 adults with mild head injuries will be randomly assigned to either the ultrasound-guided discharge or standard care. The goal is to see if the ultrasound approach is just as good at preventing long-term problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

550 people

The number who actually took part.

Started

Feb 2020

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Brain Concussion traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mild traumatic brain injury

Contacts and locations

Locations

  • AP-HP Lariboisière

    Paris, France

  • AP-HP Pitié Salpetrière

    Paris, France

  • CH Melun

    Melun, France

  • CHU Clermont-Ferrand

    Clermont-Ferrand, France

  • CHU Grenoble Alpes

    Grenoble, France

  • CHU Nantes

    Nantes, France

  • CHU Poitiers

    Poitiers, France

  • CHU Réunion

    Saint-Denis, 97400, France

  • CHU Toulouse

    Toulouse, France

  • Chu Reunion

    Saint-Pierre, 97448, France

  • HCL - Edouard Herriot

    Lyon, France

  • HCL - Lyon Sud

    Lyon, France

More trials for these conditions

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