Authorised Therapeutic exploratory (Phase II) Aneyrysmal subarachnoid hemorrhage needing ventilatory care in intensive care unit

Effect of xenon on brain injury, neurological outcome and survival in patients after aneurysmal subarachnoid hemorrhage

EU CTIS ID: 2022-500596-32-00

What this study is testing

To explore neuroprotective properties of xenon in patients after aneurysmal subarachnoid hemorrhage (SAH).

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • To be considered eligible to participate in this study, a SAH subject must meet the inclusion criteria listed below: 1. Informed consent obtained from the next of kin or legal representative 2. Aneurysmal subarachnoid hemorrhage visible on CTA or DSA. 3. Deterioration of consciousness to Hunt-Hess 3-5 4. Age of ≥ 18 years 5. Intubated. 6. GCS 3–12 obtained off neuromuscular blocking agents 7. Xenon treatment can be started within 6 hours after loss of consciousness 8. The interval between the estimated onset of bleeding and the occurrence of loss of consciousness must not exceed 12 hours.

You likely can't join if

  • Acute or chronic traumatic brain injury
  • Current enrollment in another interventional study
  • The subject is known to have clinically significant laboratory abnormality, medical condition (such as decompensated liver disease or severe chronic obstructive pulmonary disease), or social circumstance that, in the investigator’s opinion, makes it inappropriate for the subject to participate in this clinical trial
  • Presence of implants or foreign bodies which are not known to be MRI safe
  • Maximum diameter of intracerebral hemorrhage > 2.5 cm
  • Pneumothorax or pneumomediastinum
See the full eligibility criteria
Who can join
  • To be considered eligible to participate in this study, a SAH subject must meet the inclusion criteria listed below: 1. Informed consent obtained from the next of kin or legal representative 2. Aneurysmal subarachnoid hemorrhage visible on CTA or DSA. 3. Deterioration of consciousness to Hunt-Hess 3-5 4. Age of ≥ 18 years 5. Intubated. 6. GCS 3–12 obtained off neuromuscular blocking agents 7. Xenon treatment can be started within 6 hours after loss of consciousness 8. The interval between the estimated onset of bleeding and the occurrence of loss of consciousness must not exceed 12 hours.
What rules you out
  • Acute or chronic traumatic brain injury
  • Current enrollment in another interventional study
  • The subject is known to have clinically significant laboratory abnormality, medical condition (such as decompensated liver disease or severe chronic obstructive pulmonary disease), or social circumstance that, in the investigator’s opinion, makes it inappropriate for the subject to participate in this clinical trial
  • Presence of implants or foreign bodies which are not known to be MRI safe
  • Maximum diameter of intracerebral hemorrhage > 2.5 cm
  • Pneumothorax or pneumomediastinum
  • Acute lung injury requiring ≥ 60% FIO2 (fraction of inspired oxygen)
  • Systolic arterial pressure < 80 mmHg or mean arterial pressure < 60 mmHg for over 30 min period
  • Bilaterally fixed and dilated pupils
  • Positive pregnancy test, known pregnancy, or current breast-feeding
  • Neurological deficiency due to traumatic brain injury or other neurological illness
  • Imminent death or current life-threatening disease

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.