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Study on the Effects of Xenon and Oxygen on Brain Injury and Recovery in Patients with Aneurysmal Subarachnoid Hemorrhage in Intensive Care

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What is this study about?

This clinical trial is focused on studying the effects of the gas xenon on patients who have experienced a type of brain bleed known as aneurysmal subarachnoid hemorrhage. This condition occurs when a blood vessel on the surface of the brain bursts, leading to bleeding in the space around the brain. The study aims to explore whether xenon can help protect the brain and improve recovery after such an event. Patients in this study will receive xenon through inhalation, which means they will breathe it in as a gas. The study will also involve the use of oxygen as a part of the treatment process.

The purpose of the study is to investigate the potential benefits of xenon in reducing brain injury and improving neurological outcomes and survival rates in patients who have suffered from aneurysmal subarachnoid hemorrhage. Participants will be monitored for changes in their brain’s white matter, which is a part of the brain that helps with communication between different brain regions. The study will also assess the safety and tolerability of xenon by comparing the number of adverse events, or unwanted effects, between those receiving xenon and those who do not.

Throughout the study, participants will undergo various assessments, including MRI scans, to evaluate the condition of their brain. The study will last for a period of time, with follow-ups to monitor the long-term effects of the treatment. The goal is to determine if xenon can provide a protective effect on the brain and improve the overall recovery and quality of life for patients who have experienced this serious type of brain bleed.

1 joining the study

Upon joining the study, informed consent is obtained from your next of kin or legal representative. This is necessary because the study involves patients with a specific type of brain injury called aneurysmal subarachnoid hemorrhage.

You will be eligible if you meet certain criteria, such as being 18 years or older, having a specific level of consciousness, and being intubated. The treatment with xenon can start within 6 hours after the onset of symptoms.

2 treatment phase

During the treatment phase, you will receive xenon through inhalation. This is a medicinal gas that is administered to explore its protective effects on the brain.

The treatment aims to reduce brain injury and improve neurological outcomes. The exact dosage and frequency will be determined by the medical team based on your condition.

3 monitoring and assessments

Throughout the trial, your condition will be closely monitored. This includes regular assessments using imaging techniques like MRI to evaluate the effects of the treatment on your brain.

Safety and tolerability of the xenon treatment will be assessed by monitoring any adverse events or unexpected reactions.

4 follow-up period

After the initial treatment phase, there will be a follow-up period lasting up to one year. During this time, your recovery and neurological outcomes will be evaluated.

The follow-up includes monitoring for any long-term effects of the treatment and assessing your overall health and recovery progress.

Who Can Join the Study?

  • Informed consent must be obtained from the next of kin or legal representative. This means that a family member or legal guardian must agree to the patient’s participation in the study.
  • The patient must have an aneurysmal subarachnoid hemorrhage visible on a CTA (Computed Tomography Angiography) or DSA (Digital Subtraction Angiography). These are imaging tests that show blood vessels in the brain.
  • The patient’s level of consciousness must have deteriorated to a Hunt-Hess grade of 3 to 5. This is a scale used to measure the severity of a brain hemorrhage.
  • The patient must be at least 18 years old.
  • The patient must be intubated, meaning they have a tube inserted into their airway to help them breathe.
  • The patient must have a GCS (Glasgow Coma Scale) score of 3 to 12 when not under the influence of drugs that block muscle movement. The GCS is a scale used to assess a person’s level of consciousness.
  • Xenon treatment must be able to start within 6 hours after the onset of symptoms of the subarachnoid hemorrhage.

Who Cannot Join the Study?

  • Patients who have a serious infection that is not controlled. This means an infection that is not being effectively treated or managed.
  • Patients with severe heart problems. This includes conditions where the heart is not functioning properly.
  • Patients who have had a stroke in the past 6 months. A stroke is when blood flow to a part of the brain is stopped or reduced.
  • Patients with severe liver disease. This refers to serious conditions affecting the liver, an organ that helps process substances in the body.
  • Patients with severe kidney disease. This means the kidneys, which filter waste from the blood, are not working well.
  • Patients who are pregnant or breastfeeding. This means women who are expecting a baby or are nursing a child.
  • Patients who have a known allergy to xenon or any other component used in the study. An allergy is a reaction by the immune system to something that is usually harmless.
  • Patients who are participating in another clinical trial. This means being involved in another study at the same time.
  • Patients with mental health conditions that might interfere with the study. This includes conditions that affect mood, thinking, and behavior.
  • Patients who have a history of substance abuse. This refers to the misuse of drugs or alcohol.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Kuopio University Hospital Kuopio Finland
Turku University Hospital Turku Finland
Pirkanmaan hyvinvointialue Tampere Finland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Finland Finland
Recruiting
01.10.2024

Trial locations

Investigated drugs:

Xenon is a gas that is being studied for its potential to protect the brain after a specific type of bleeding in the brain called aneurysmal subarachnoid hemorrhage. In this trial, researchers are looking at how xenon might help improve brain function and survival in patients who have experienced this kind of brain injury. Xenon is thought to have properties that could help shield the brain from further damage after the initial injury.

Aneurysmal Subarachnoid Hemorrhage – Aneurysmal subarachnoid hemorrhage occurs when a blood vessel on the surface of the brain bursts, leading to bleeding in the space between the brain and the surrounding membrane. This condition often results from a ruptured aneurysm, which is a weakened area in a blood vessel wall. The bleeding can increase pressure on the brain, leading to symptoms such as a sudden severe headache, neck stiffness, and sensitivity to light. As the condition progresses, it may cause confusion, seizures, or loss of consciousness. The initial bleeding can also lead to complications like rebleeding or vasospasm, where blood vessels constrict and reduce blood flow to the brain. Over time, this can result in further brain injury or neurological deficits.

Trial ID:
2022-500596-32-00
Protocol code:
T109/2019Xe-SAH
NCT ID:
NCT04696523
Trial Phase:
Therapeutic exploratory (Phase II)

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