BridgeMD
New treatment option for Subarachnoid Hemorrhage, Aneurysmal
Official title Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage
ClinicalTrials.gov ID: NCT04696523
What this study is testing
What is Xenon?
Xenon is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for subarachnoid hemorrhage, aneurysmal.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- An investigator-initiated clinical drug study Main Objective: To explore neuroprotective properties of xenon in patients after aneurysmal subarachnoid hemorrhage (SAH). Primary endpoint: Global fractional anisotropy of white matter of diffusion tensor imaging (DTI).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- To be considered eligible to participate in this study, a SAH subject must meet the listed below:
- Informed consent obtained from the next of kin or legal representative
- Aneurysmal subarachnoid hemorrhage visible on CTA or DSA.
- Deterioration of consciousness to Hunt-Hess 3-5
- Age of ≥ 18 years
You likely can't join if
- An aSAH subject may not be enrolled in the trial if he/she meets any one of the exclusion criteria below:
- Acute or chronic traumatic brain injury
- 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
See the full eligibility criteria
- To be considered eligible to participate in this study, a SAH subject must meet the listed below:
- Informed consent obtained from the next of kin or legal representative
- Aneurysmal subarachnoid hemorrhage visible on CTA or DSA.
- Deterioration of consciousness to Hunt-Hess 3-5
- Age of ≥ 18 years
- Intubated.
- GCS 3-12 obtained off neuromuscular blocking agents
- Xenon treatment can be started within 6 hours after onset of SAH symptoms
- An aSAH subject may not be enrolled in the trial if he/she meets any one of the exclusion criteria below:
- Acute or chronic traumatic brain injury
- 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
- Current enrollment in another treatment 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...
- Presence of implants or foreign bodies which are not known to be MRI safe
The study team makes the final eligibility decision.
Where it's taking place
- Helsinki, Helsinki, Finland
- Kuopio, Kuopio, Finland
- Tampere, Pirkanmaa, Finland
- Turku, Turku, Finland
- Örebro, Örebro County, Sweden
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Helsinki, Helsinki, Finland; Kuopio, Kuopio, Finland; Tampere, Pirkanmaa, Finland; Turku, Turku, Finland; Örebro, Örebro County, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.