Targeting Spreading Depolarization After Chronic Subdural Hematoma Surgery (TASD) (NCT04966546) | Clinical Trial Compass
WithdrawnEarly Phase 1
Targeting Spreading Depolarization After Chronic Subdural Hematoma Surgery (TASD)
Stopped: Loss of Departmental support
United States0Started 2022-06-01
Plain-language summary
Chronic Subdural Hematoma (cSDH) is an extremely common problem, particularly in the aging population, where fluid like collections compress the brain, frequently requiring surgical drainage. After drainage, 25-50% of patients experience post operative neurologic deficits such as weakness or confusion that are often not explained by problems such as seizure, stroke, or mass effect from the fluid and blood. Recent subdural recordings have demonstrated that some of these neurological deficits may be related to waves of spreading depolarization (SD), which cause temporary neurological dysfunction. Our overall objective is to examine the relationship between neurological deficits and SD and to assess feasibility of a pilot trial to determine if a strategy of NMDA-R antagonism can effectively reduce SD and improve clinical recovery.
Who can participate
Age range
18 Years – 100 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:
* Surgical intervention for chronic or subacute SDH
* Electrode strip placed at time of surgery (for clinical indication of enhanced seizure monitoring)
* Age 18-100
* SD detected within 48h of surgery
Exclusion Criteria:
* Acute SDH requiring large craniotomy (some acute subacute component within cSDH is acceptable)
* Strip not feasible or safe to place at conclusion of surgery
* Known or suspected infection
* Recurrent surgery
* Subjects who previously participated in the study (contralateral or recurrent hematoma)
* Severe renal impairment (CrCl 5-29)
* Use of other NMDA antagonist
* Severe hepatic impairment
* Child-Pugh Class C hepatic impairment
* Known allergy to memantine
* Memantine use at time of admission
* Inability to obtain enteral feeding (oral or via NGT)
* Patients on acetylcholinesterase inhibitors
* Women of child-bearing age who are unwilling to undergo dual contraception for 30 days.
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.