Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Salt water infusion could boost brain injury recovery

NCT ID NCT07319208

Disease control Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Updated 2 times

Summary

This study tests whether giving a continuous infusion of concentrated salt water (hypertonic saline) early after severe traumatic brain injury can improve survival and daily living independence at 6 months. About 760 patients with a low Glasgow Coma Scale score and high risk of brain swelling will receive the infusion for 48 hours. The goal is to reduce pressure inside the skull and protect the brain.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hypertonic saline solution (concentrated salt water)
What this could lead to
If it works, this could offer a simple, widely available treatment to help more people survive traumatic brain injury and regain independence.
What could go wrong
This is a large phase 3 trial, but the treatment is only for a specific high-risk group and may not improve outcomes for all. Side effects like high sodium or chloride levels need careful monitoring.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 760 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jun 2029

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 75 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: * Patient admitted to intensive care unit * Traumatic brain injury with Glasgow Coma Scale ≤ 12 * Intracranial pressure (ICP) monitoring based on the attending physician's clinical judgment, in accordance with guidelines or clinical/radiological signs considered at risk of intracranial hypertension * Inclusion during the first 12 hours after Intracranial pressure monitoring placement * Informed and signed consent * National health insurance Exclusion Criteria: * Glasgow Coma Scale (score = 3) and persistent abnormal pupillaryreactivity despite urgent therapy * Associated cervical spinal cord injury * Imminent death and do-not-resuscitate orders * Coma secondary to cardiac arrest * Pregnancy (serum or urine test performed in routine care) * Severe Cardiac insufficiency * Severe chronic renal insufficiency * Severe hepatic insufficiency: patient presenting with oedemato-ascitic decompensation of liver cirrhosis or patient with Child-Pugh class C cirrhosis * High risk of follow-up difficulties after ICU discharge * Patients under court protection * Patient who does not speak French

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for TBI (traumatic brain injury) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

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

TBI (traumatic brain injury)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    23 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP-HM

    NOT_YET_RECRUITING

    Marseille, France

  • CH de Annecy Genevois

    NOT_YET_RECRUITING

    Épagny, France

  • CHRU de Tours

    NOT_YET_RECRUITING

    Tours, France

  • CHU Caen Normandie

    RECRUITING

    Caen, France

  • CHU Henri Mondor APHP

    RECRUITING

    Créteil, France

  • CHU Lariboisière, AP-HP

    NOT_YET_RECRUITING

    Paris, France

  • CHU d'Angers

    NOT_YET_RECRUITING

    Angers, France

  • CHU de Brest

    RECRUITING

    Brest, France

  • CHU de Clermont- Ferrand

    RECRUITING

    Clermont-Ferrand, France

  • CHU de Grenoble

    NOT_YET_RECRUITING

    Grenoble, France

  • CHU de Lille

    RECRUITING

    Lille, France

  • CHU de Nancy

    NOT_YET_RECRUITING

    Nancy, France

  • CHU de Nantes

    RECRUITING

    Nantes, France

  • CHU de Nice

    RECRUITING

    Nice, France

  • CHU de Poitiers

    NOT_YET_RECRUITING

    Poitiers, France

  • CHU de Rennes

    RECRUITING

    Rennes, France

  • CHU de Rouen

    NOT_YET_RECRUITING

    Rouen, France

  • CHU de St- Etienne

    NOT_YET_RECRUITING

    Saint-Etienne, France

  • CHU de Strasbourg

    NOT_YET_RECRUITING

    Strasbourg, France

  • CHU de Toulouse

    RECRUITING

    Toulouse, France

  • GHU Paris Cité

    NOT_YET_RECRUITING

    Paris, France

  • HCL

    NOT_YET_RECRUITING

    Lyon, France

  • Hôpital BEAUJON APHP

    RECRUITING

    Clichy, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.