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Xenon

Clinical trials are investigating Xenon in patients with aneurysmal subarachnoid hemorrhage who need ventilatory care in the intensive care unit. These studies aim to see whether Xenon can improve brain injury, neurological outcome, and survival, with safety and imaging-based effects measured in a phase 2 trial.

Table of Contents

Trial overview

The clinical trial NCT04696523 is studying Xenon in patients after aneurysmal subarachnoid hemorrhage, also called SAH.[1] The study is authorised and is being done to explore possible neuroprotective effects, which means protection of the brain after injury.[1]

Population and setting

This trial focuses on patients with aneurysmal subarachnoid hemorrhage who need ventilatory care in the intensive care unit.[1] In simple words, this means the study is looking at people who are seriously ill and need breathing support and close hospital monitoring.[1]

Study design and phase

The study is an interventional trial, which means researchers give a treatment and compare it with another study treatment.[1] It is a Phase 2 trial, so the main goal is to learn more about whether Xenon may help and to continue checking its effects in this patient group.[1] The planned enrollment is 160 patients.[1]

Outcomes and endpoints

The primary endpoint is global fractional anisotropy of white matter measured by diffusion tensor imaging, which is a special MRI method.[1] This measure is used to see how much the brain’s white matter has been damaged.[1] The study hypothesis is that white matter damage will be less severe in patients treated with Xenon, meaning the Xenon group is expected to have a higher global fractional anisotropy score than the control group on the first MRI scan.[1]

Interventions and comparator

The study intervention includes Xenon given by inhalation.[1] The control treatment is CONOXIA 100% medical gas, also given by inhalation.[1] The trial data do not provide more detail about how the groups are compared beyond these study treatments.[1]

What this means for patients

For patients and families, this trial is asking whether Xenon can help limit brain injury after a very serious type of brain bleed.[1] The main focus is not just survival, but also brain structure on MRI and neurological outcome, which means how well the brain and nervous system recover.[1] Based on the available trial data, this study is early-stage research and is aimed at a critically ill hospital population.[1]

Trial ID Phase Condition studied Status Enrollment
NCT04696523 Phase 2 Aneurysmal subarachnoid hemorrhage needing ventilatory care in intensive care unit Authorised 160

FAQ

  • What is being studied in the Xenon trials? The trial is studying whether Xenon can help protect the brain after aneurysmal subarachnoid hemorrhage. It also looks at neurological outcome and survival.
  • Who can take part in the trial? The trial is for patients with aneurysmal subarachnoid hemorrhage who need ventilatory care in the intensive care unit. The study data do not list other participation details.
  • What phase is the Xenon trial? This study is a phase 2 trial. Phase 2 studies usually look more closely at whether a treatment may work and continue to check safety.
  • What condition is the trial focused on? The trial focuses on aneurysmal subarachnoid hemorrhage, which is bleeding around the brain caused by a burst aneurysm. It is a serious brain injury that often needs intensive care.
  • What is the main outcome being measured? The main outcome is global fractional anisotropy of white matter on diffusion tensor imaging. This MRI measure is used to see how much the brain’s white matter has been damaged.

Ongoing Clinical Trials on Xenon

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

    Recruiting

    1 1 1
    Investigated drugs:
    Finland

Glossary

  • Aneurysmal subarachnoid hemorrhage: Bleeding around the brain caused by a burst aneurysm, which is a weak bulge in a blood vessel.
  • Ventilatory care: Breathing support given when a patient cannot breathe well enough on their own.
  • Intensive care unit: A hospital unit for patients who need very close monitoring and advanced treatment.
  • Interventional study: A clinical trial where researchers give a treatment and compare it with another treatment or control.
  • Phase 2: A trial stage that looks more closely at whether a treatment may work and continues to monitor safety.
  • Primary endpoint: The main result the researchers plan to measure to judge the study.
  • Diffusion tensor imaging: A type of MRI scan that shows how water moves in brain tissue and can help detect white matter damage.
  • Fractional anisotropy: A number from brain imaging that helps show how healthy or damaged white matter is.
  • White matter: Part of the brain made of nerve fibers that help signals travel between brain areas.
  • Neurological outcome: How well the brain and nervous system are working after an illness or injury.
  • Survival: Whether patients are alive after the treatment or study period.

References