Optic Nerve Sonography to Monitor Intracranial Pressure After Ischemic sTrokE - The ONSITE Study (NCT06939114) | Clinical Trial Compass
CompletedNot Applicable
Optic Nerve Sonography to Monitor Intracranial Pressure After Ischemic sTrokE - The ONSITE Study
Switzerland107 participantsStarted 2019-01-01
Plain-language summary
The goal of the ONSITE study is to investigate whether an increase Optic nerve sheath diameter (ONSD) may help to predict intracranial hypertension (IH) after stroke. IH is a life-threatening complicaitons of malignant middle cerebral artery (MCA) infarction due to space-occupying brain edema. Patients at risk are monitored based on clinical symptoms, which can be difficult due to comorbidities such as delirium or systemic infections, which can hempen clinical judgement. Readily available, non-invasive methods to monitor ICP in stroke patients could help to earlier diagnose rising ICP and facilitate treatment decisions such as hemicraniectomy. This study investigates whether ONSD with optic nerve sonography (ONS) can detect brain edema after stroke.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥ 18 years of age
* Consent according to the regulations of research in an emergency situation
* For non-Control patients: Acute ischemic stroke within 24 hours of recruitment
Exclusion Criteria:
* Known intracranial space-occupying lesion
* Known history of intracranial hypertension
* Contra-indications on ethical grounds
* Expected or known non-compliance to participate in the observational study, severe drug- or/and alcohol abuse
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Presence of intracranial hypertension
Timeframe: Assessed at Baseline, at 12 hours after stroke, at 24 hours after stroke, at 36 hours after stroke, at 48 hours after stroke, at 72 hours after stroke, at 120 hours after stroke.