UnknownNot Applicable

Early Warning of Delayed Cerebral Ischemia

Lithuania250 participantsStarted 2021-09-21

Plain-language summary

The goal of this observational study is to learn about the possibility to predict clinical course of subarachnoid hemorrhage (SAH) patients by performing the retrospective analysis of clinical data available in early pre-vasospasm phase. The main questions it aims to answer are: * What biomarkers retrieved from Computed Tomography (CT) and Computed Tomography Angiography (SAH location, leaked blood volume, cerebrospinal fluid volume, etc.) can be used to predict development of cerebral vasospasms, delayed cerebral ischemia and patients' outcome. * What biomarkers retrieved from transcranial Doppler examinations in early pre vasospasm can be used to predict development of cerebral vasospasms, delayed cerebral ischemia and patients' outcome. * What biomarkers retrieved from multimodal physiological monitoring in early pre vasospasm can be used to predict development of cerebral vasospasms, delayed cerebral ischemia and patients' outcome. * What is impact of other clinical data (blood test results, age, gender, etc.) on development of cerebral vasospasms and delayed cerebral ischemia.

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: * Subarachnoid hemorrhage patients who require SAH surgery and post-operative routine treatment. Exclusion Criteria: * persons with mental disorders, but who can give consent to participate in biomedical research; * minors; * students, if their participation in biomedical research is related to studies; * persons living in care institutions; * soldiers during their actual military service; * employees of health care institutions where biomedical research is conducted, subordinate to the researcher;

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

Cerebral vasospasms

Timeframe: CTA is performed routinely on 7th day after SAH or within period of 3-21 day after SAH if necessary

Delayed cerebral ischemia

Timeframe: CT is performed routinely on 7th day after SAH or within period of 3-21 day after SAH if necessary

Patient outcome

Timeframe: GOS is evaluated at discharge from hospital and after 30 days after SAH

Trial details

NCT IDNCT06006975

SponsorVilnius University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-08

Contact for this trial

Saulius Rocka, Prof. Dr.

+37068743480 saulius.rocka@santa.lt

View on ClinicalTrials.gov More Subarachnoid Hemorrhage, Aneurysmal trials