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Study on Anakinra for Patients with Intracerebral Hemorrhage to Reduce Brain Swelling After Stroke

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 is focused on studying the effects of the medication anakinra on patients who have experienced a type of stroke known as intracerebral hemorrhage. This condition occurs when there is bleeding within the brain, which can lead to swelling and further injury. The purpose of the study is to understand how different doses of anakinra affect the development of brain swelling after such a stroke.

Participants in the study will receive either a high dose or a low dose of anakinra, or they will continue with standard medical care. The medication is administered as an injection. The study will monitor the effects of the treatment over a period of time, looking specifically at how it impacts brain swelling, which will be assessed using MRI scans. Additionally, the study will track any side effects and changes in certain blood markers that indicate inflammation.

The trial aims to provide valuable insights into whether anakinra can help reduce the harmful effects of brain swelling following an intracerebral hemorrhage. This could potentially lead to improved treatment options for patients who suffer from this serious condition. The study is expected to continue until 2025, with recruitment starting in late 2024.

The research process

The trial runs in 5 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, you will be required to provide informed consent. This means you agree to participate after understanding the details and potential risks of the trial.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes verifying that you are at least 18 years old and have a confirmed supratentorial non-traumatic intracerebral hemorrhage (ICH) with a minimum volume of 10 mL.

    The assessment will also ensure that the intervention can start within 8 hours from the onset of symptoms.

  3. Step 3

    Treatment administration

    You will receive the medication anakinra through an injection. The dosage will be determined as either high-dose or low-dose, based on the study requirements.

    The frequency and duration of the administration will be explained to you by the medical team.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, you will undergo regular monitoring to assess the development of cerebral edema, which is swelling in the brain. This will be done using MRI scans.

    Your health will be closely monitored for any adverse events, and blood tests will be conducted to measure inflammatory markers.

  5. Step 5

    Completion of the trial

    At the end of the trial, your overall health and recovery will be evaluated using various scales and scores, such as the mRS, Barthel index, and EQ-5D-5L.

    The trial is expected to conclude by September 30, 2025.

Who can join the trial?

6 criteria

  • Age must be 18 years or older.
  • Must have a type of bleeding in the brain called supratentorial non-traumatic intracerebral hemorrhage (ICH), confirmed by a CT scan. This means the bleeding is not caused by an injury and is located in a specific part of the brain.
  • The CT scan must not show any other cause for the bleeding, such as an aneurysm (a bulge in a blood vessel), AVM (abnormal connection between arteries and veins), DAVF (abnormal connection between a brain artery and a vein), or a blood clot in the brain's veins.
  • The bleeding must be at least 10 mL in volume.
  • The treatment must be able to start within 8 hours from when symptoms begin.
  • The patient or their legal representative must give informed consent, meaning they agree to participate after understanding the study details.

Who cannot join the trial?

3 criteria

  • Patients who have had a recent **intracerebral haemorrhage** (bleeding inside the brain).
  • Patients who are not within the age range of 18 to 65 years old.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Anakinra is a medication used in this clinical trial to help reduce inflammation in the brain after a type of stroke called a cerebral hemorrhage. When a person has a cerebral hemorrhage, blood leaks into the brain, which can cause swelling and damage. Anakinra works by blocking a specific protein in the body that causes inflammation, which may help reduce the swelling and prevent further injury to the brain. In this trial, researchers are studying how effective Anakinra is in reducing brain swelling compared to standard medical treatments.

What is already known about the treatment

Anakinra – Anakinra is administered as an injection under the skin, typically in the arm, thigh, or abdomen. It is currently being studied in clinical trials for its potential to reduce brain swelling after a type of stroke called intracerebral hemorrhage. The main therapeutic use being explored is its ability to target and reduce inflammation in the brain, which can help prevent further injury after a stroke. At the molecular level, Anakinra works by blocking a specific protein called interleukin-1, which plays a key role in the body's inflammatory response. It is classified as an interleukin-1 receptor antagonist in pharmacology.

Investigated diseases

Intracerebral haemorrhage – This condition involves bleeding within the brain tissue itself, which can lead to increased pressure in the brain. It often occurs suddenly and can cause symptoms such as headache, weakness, confusion, and difficulty speaking. As the bleeding continues, it can result in the accumulation of blood, forming a mass known as a hematoma. This mass can disrupt normal brain function by compressing surrounding tissues. Over time, the body may absorb the blood, but the initial damage can lead to lasting effects. The progression of this condition can vary depending on the size and location of the hemorrhage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517230-17-00Protocol code109883Estimated enrolment75 patientsSponsorStichting Radboud universitair medisch centrum

sourced from the EU Clinical Trials Register and site verification

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