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Study of hypertonic saline solution and mannitol to improve recovery in patients with traumatic brain injury and high risk of intracranial hypertension

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with traumatic brain injury, a condition where the brain is damaged due to external force or trauma. The study aims to evaluate whether giving a continuous infusion of hypertonic saline solution through a vein early in treatment can help improve survival and the ability to perform daily activities in patients who are at high risk of increased pressure inside the skull.

The study will use two treatments: sodium chloride solution and mannitol solution, both given through an intravenous line. These medications help control the pressure inside the brain after injury. Patients will receive treatment for up to 7 days while being monitored in an intensive care unit.

The study will track how well patients recover over time, particularly focusing on their survival after 3 months and their ability to perform daily activities independently after 6 months. Doctors will monitor various aspects of patient health, including salt levels in the blood and kidney function, to ensure the treatment is safe. The evaluation of how well patients recover will be done by medical professionals who do not know which treatment the patient received.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial admission and monitoring

    You will be admitted to the intensive care unit within 12 hours of having a device placed to monitor your brain pressure

    Your condition must meet specific criteria, including a Glasgow Coma Scale score of 12 or lower (a measure of consciousness level)

  2. Step 2

    Treatment administration

    You will receive either hypertonic saline solution or standard treatment through an intravenous line

    The treatment will be administered continuously through your veins

    Medical staff will monitor your brain pressure regularly

  3. Step 3

    7-day monitoring period

    During the first 7 days, medical staff will closely monitor your:

    - Blood sodium levels

    - Blood chloride levels

    - Blood concentration (osmolarity)

    Your treatment intensity will be assessed during this period

  4. Step 4

    Follow-up at 1 month

    Medical staff will check for any kidney problems

    Your overall health status will be evaluated

    You will complete a quality of life questionnaire

  5. Step 5

    Follow-up at 3 months

    Your survival and recovery progress will be assessed

    You will complete another quality of life questionnaire

  6. Step 6

    Final evaluation at 6 months

    A specialist will evaluate your ability to perform daily activities

    You will undergo cognitive function tests

    Your overall recovery and independence level will be assessed

    You will complete a final quality of life questionnaire

  7. Step 7

    Extended follow-up at 12 months

    Final survival assessment will be conducted

    You will complete a final quality of life questionnaire

    Your living situation will be documented

Who can join the trial?

8 criteria

  • Must be between 18 and 75 years old
  • Must be a patient in the intensive care unit (specialized hospital department for critically ill patients)
  • Must have a traumatic brain injury with a Glasgow Coma Scale score of 12 or less (a scale that measures consciousness level, where lower scores indicate more severe injury)
  • Must be enrolled within 12 hours after having a device placed to monitor brain pressure
  • Must have intracranial pressure monitoring (a device that measures pressure inside the skull) as determined necessary by the doctor
  • Must provide informed consent with signature (written permission to participate in the study)
  • Must have national health insurance coverage
  • Can be either male or female

Who cannot join the trial?

15 criteria

  • Age under 18 years or over 65 years
  • Pregnant or breastfeeding women
  • Patients with known kidney failure (when kidneys don't work properly)
  • Patients with severe heart conditions
  • Previous brain surgery
  • Patients with multiple trauma (injuries to more than one body part)
  • Patients who cannot give informed consent
  • Patients with blood clotting disorders (conditions that affect blood's ability to form clots)
  • Patients currently participating in other clinical trials
  • Patients with known allergies to the study medication
  • Patients with uncontrolled high blood pressure (consistently high blood pressure despite treatment)
  • History of severe neurological disorders (serious conditions affecting the brain and nervous system)
  • Patients who have received other experimental treatments within the past 30 days
  • Patients with life-threatening infections
  • Patients with severe liver disease
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Investigated drugs

Hypertonic Saline Solution (HSS) is a medical treatment that contains a higher concentration of salt (sodium chloride) than what is normally found in the body. When given through an intravenous (IV) line continuously, it helps reduce swelling in the brain that can occur after a traumatic head injury. This solution works by drawing excess fluid out of brain tissue, which can help decrease pressure inside the skull. This treatment is commonly used in intensive care units to manage patients with severe brain injuries.

What is already known about the treatment

Hypertonic Saline Solution (HSS) - An intravenous medication administered as a continuous infusion that contains a higher concentration of sodium chloride than normal saline solution. It is primarily used in the management of traumatic brain injury to help reduce intracranial pressure and prevent secondary brain damage by creating an osmotic gradient that draws excess fluid from brain tissue. This treatment belongs to the class of hyperosmolar agents and works by increasing serum osmolality, which helps control cerebral edema and improve cerebral blood flow. HSS has shown promising results in clinical trials for improving survival rates and functional outcomes in patients with severe traumatic brain injury, particularly when administered early in the treatment course.

Investigated diseases

Traumatic Brain Injury - A condition that occurs when an external force causes damage to the brain, disrupting its normal function. The injury typically results from a violent blow or jolt to the head, which can cause bruising, bleeding, or tearing of brain tissue. Brain tissue may swell following the injury, which can increase pressure within the skull. The condition can affect various brain functions including consciousness, memory, movement, and behavior. The effects may be temporary or long-lasting, depending on the severity and location of the injury.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520205-39-00Protocol codeRC24_0543Estimated enrolment760 patientsSponsorCentre Hospitalier Universitaire De Nantes

sourced from the EU Clinical Trials Register and site verification

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