Study of Stroke Related Edema Treatments (NCT01954290) | Clinical Trial Compass
WithdrawnPhase 2
Study of Stroke Related Edema Treatments
Stopped: Investigator is leaving the institution.
0Started 2015-09
Plain-language summary
Stroke remains the fourth leading cause of death in the United States (second worldwide) and a leading cause of long-term disability, resulting in total direct and indirect costs of approximately $73.7 billion annually. The failure of novel therapies in clinical trials demonstrates that the complex neural response to stroke must be targeted at multiple levels to improve patient outcomes. Despite significant improvements in stroke treatment and management, 1 year survival rate among stroke patients aged 65 years or more is around 25%, and 5- year survival rate amounts to approximately 50%. The highest chances of death are within 30 days of stroke. Mortality increases due to worsening brain dysfunction, elevated intracranial pressure (ICP), and other comorbid conditions.
Treatments aimed at reducing post-stroke cytotoxic edema may reduce the risk for development of malignant stroke and mortality. Current treatments such as osmo-therapy and hemicraniectomy have substantial limitations, and mortality remains high, despite these measures outcomes remain unsatisfactory. There is a great need for alternative medical approaches which are safe, predictable, and help to ameliorate post stroke edema.
Who can participate
Age range
18 Years – 80 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:
* Subjects with age ≥18 years and ≤80 years at the time of screening.
* Hemorrhagic stroke or large vessel ischemic stroke patients diagnosed by MRI or CT scan of Head.
* Subjects who have presented to hospital within 24 hours of symptom onset.
* The subject or his/ her legal representative is willing to undergo informed consent process prior to enrollment into this study.
Exclusion Criteria:
* Subject with age \< 18 years and \>80 years at the time of screening.
* Subjects with absence of stroke by imaging of brain by CT scan or MRI.
* Lacunar stroke or small vessel stroke.
* Time of symptom onset cannot be determined.
* Subjects with renal or hepatic failure.
* Subjects with hypovolemia or hypotension as determined by the study team.
* Subjects with hypernatremia.
* Subject who is pregnant or lactating.
* Subject is already participating in other investigational clinical trial.
* The subject or legal representative is unable to provide informed consent.
* The subject is medically unstable to participate in the trial as determined by the principal investigator.
* The subject has any end stage medical condition as determined by the principal investigator.
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
Modified Rankin Score
Timeframe: At the time of discharge from hospital, and 3 months after initial event
2
National Institutes of Health Stroke Severity (NIHSS) scale
Timeframe: At the time of discharge from hospital, and 3 months after initial event
3
Neurological status of the subject
Timeframe: At the time of discharge from hospital, and 3 months after discharge