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Study on Esketamine Hydrochloride and Sodium Chloride for Patients with Severe Acute Brain Injury

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What is this trial about?

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

This clinical trial is focused on studying the effects of the medication Esketamine Hydrochloride on patients who have experienced severe acute brain injuries, such as subarachnoid hemorrhage, intracerebral hemorrhage, or traumatic brain injury. These conditions involve bleeding in or around the brain, which can lead to serious complications. The trial will also use Sodium Chloride as a comparison treatment. The purpose of the study is to investigate how effective and safe Esketamine Hydrochloride is in reducing the occurrence of a specific type of brain activity called cortical spreading depolarisations, which can happen after a brain injury.

Participants in the study will receive either Esketamine Hydrochloride or Sodium Chloride through an infusion, which is a method of delivering medication directly into the bloodstream. The treatment will last for a maximum of 14 days. During this time, researchers will monitor the patients to see how often these brain activities occur and to check for any side effects or reactions to the treatment. The study aims to understand if Esketamine Hydrochloride can help patients whose brain activities continue despite other treatments.

After the treatment period, the study will continue to follow up with participants to assess their recovery and overall health outcomes. This will include evaluating their functional abilities six months after the treatment using standard scales like the modified Rankin Scale and the Glasgow Outcome Scale-Extended. The results of this study could provide valuable insights into new treatment options for individuals with severe brain injuries.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age (18 years or older) and diagnosis of severe brain injury, including traumatic brain injury, subarachnoid hemorrhage, or intracerebral hemorrhage.

    Participation requires admission to the Neurointensive Care Unit and a planned surgery involving the brain, with continued sedation and mechanical ventilation expected post-surgery.

  2. Step 2

    Treatment administration

    The treatment involves the administration of esketamine hydrochloride and sodium chloride through infusion. The specific dosage and frequency are determined by the medical team based on individual needs.

    The objective is to assess the effectiveness and safety of esketamine in reducing cortical spreading depolarisations, which are brain waves that can occur after a severe brain injury.

  3. Step 3

    Monitoring and assessment

    Continuous monitoring is conducted to observe the occurrence of cortical spreading depolarisations per hour after the treatment begins.

    The rate of any adverse events or reactions is recorded throughout the intervention period.

  4. Step 4

    Follow-up evaluation

    A follow-up evaluation is scheduled six months after the start of the treatment to assess functional outcomes using scales such as the modified Rankin Scale and the Glasgow Outcome Scale-Extended.

    These assessments help determine the long-term effects of the treatment on recovery and daily functioning.

Who can join the trial?

8 criteria

  • Must be 18 years or older.
  • Admitted to the Neurointensive Care Unit with a diagnosis of one of the following:
    • Traumatic brain injury: An injury to the brain caused by an external force, like a fall or accident.
    • Aneurysmal subarachnoid hemorrhage: Bleeding in the space around the brain due to a burst blood vessel.
    • Spontaneous intracerebral hemorrhage: Sudden bleeding within the brain tissue itself.
    • Planned for surgery involving a supratentorial craniotomy or craniectomy:
      • Supratentorial craniotomy: A surgical procedure where a part of the skull is removed to access the upper part of the brain.
      • Craniectomy: A surgery where a portion of the skull is removed to relieve pressure on the brain.
      • Expected to continue sedation and mechanical ventilation after surgery:
        • Sedation: Use of medication to help you relax or sleep.
        • Mechanical ventilation: A machine helps you breathe.

Who cannot join the trial?

3 criteria

  • Patients with a history of **subarachnoid hemorrhage** cannot participate. This is a type of bleeding in the space around the brain.
  • Patients with a history of **intracerebral hemorrhage** cannot participate. This is bleeding inside the brain.
  • Patients with a history of **traumatic brain injury** cannot participate. This refers to damage to the brain caused by an external force, like a blow to the head.
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Investigated drugs

S-ketamine is being studied for its potential to help patients with severe acute brain injury. The trial is looking at how effective and safe S-ketamine is in reducing the occurrence of cortical spreading depolarisations (SDs), which are waves of electrical activity that can spread across the brain and may worsen brain injury. The study is also assessing how feasible it is to use S-ketamine in this setting.

What is already known about the treatment

S-ketamine – S-ketamine is administered intravenously and is currently being studied in clinical trials for its potential use in treating severe acute brain injuries, such as subarachnoid hemorrhage, intracerebral hemorrhage, and traumatic brain injury. It is being investigated for its ability to reduce cortical spreading depolarizations, which are waves of electrical disturbance in the brain that can worsen injury. S-ketamine works by blocking NMDA receptors in the brain, which are involved in the transmission of pain and the development of these depolarizations. It is classified as a dissociative anesthetic and is known for its rapid-acting antidepressant effects in other contexts.

Investigated diseases

  • Subarachnoid Hemorrhage

    This condition occurs when there is bleeding in the space between the brain and the surrounding membrane, often due to a ruptured aneurysm. It can lead to a sudden, severe headache, often described as the worst headache ever experienced. As the bleeding continues, it can cause increased pressure on the brain, leading to symptoms such as nausea, vomiting, and loss of consciousness. Over time, complications like vasospasm, where blood vessels narrow, can occur, potentially leading to further brain injury.

  • Intracerebral Hemorrhage

    This is a type of stroke caused by bleeding within the brain tissue itself, often due to high blood pressure or trauma. The bleeding can cause a sudden increase in pressure within the brain, leading to symptoms such as headache, weakness, confusion, and difficulty speaking. As the hemorrhage progresses, it can result in more severe neurological deficits and potentially lead to coma. The extent of the damage depends on the size and location of the bleed.

  • Traumatic Brain Injury

    This condition results from a blow or jolt to the head that disrupts normal brain function. Symptoms can range from mild, such as brief changes in mental status, to severe, including extended periods of unconsciousness or memory loss. The injury can cause a variety of physical, cognitive, and emotional symptoms that may appear immediately or develop over time. The progression of symptoms can vary widely depending on the severity and location of the injury.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515315-22-00Protocol codeRHNIA-001-2021Estimated enrolment400 patientsSponsorRegion Hovedstaden

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