Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma (NCT07656818) | Clinical Trial Compass
RecruitingNot Applicable
Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma
Mexico40 participantsStarted 2026-03-02
Plain-language summary
The goal of this randomized controlled trial is to evaluate whether the adjuvant application of non-thermal plasma (NTP) during standard surgical drainage of chronic subdural hematoma (cSDH) can reduce the recurrence rate at 6 months. The main questions it aims to answer are:
* Does NTP application significantly lower the radiological and clinical recurrence rate of cSDH compared to surgery alone?
* Is NTP safe when applied to the subdural space and surgical wound bed?
* Does NTP improve functional outcomes and time to hematoma resolution?
Participants will be randomly assigned to one of two groups:
* Experimental group (n = 20): Standard burr hole drainage or craniotomy plus intraoperative NTP application over the exposed dura mater, the residual membrane, soft tissue layers, and the skin incision.
* Control group (n = 20): Standard surgical drainage alone (no NTP).
Follow-up includes clinical assessments and computed tomography (CT) scans at 1 week, 3 months, and 6 months post-surgery. The primary outcome is recurrence (symptomatic reaccumulation requiring re-intervention or ≥50% volume increase on CT).
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:
* Adults ≥ 18 years of age
* Diagnosis of symptomatic chronic subdural hematoma (cSDH) requiring surgical drainage (burr hole drainage or craniotomy)
* Ability to provide written informed consent (or consent from legal representative if patient is incapacitated)
Exclusion Criteria:
* Pure acute or subacute subdural hematoma
* Uncontrolled coagulopathy or bleeding disorder
* History of intracranial aneurysm or prior cerebrovascular event with residual deficit
* Presence of active intracranial metallic implants or electronic devices (e.g., programmable shunt, cardiac pacemaker, deep brain stimulator) in the head region
* Pregnancy or lactation
* Participation in another interventional clinical trial within 30 days prior to screening
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.
1This trial uses something called non-thermal plasma during surgery for chronic subdural hematoma — can you explain in plain terms what that actually involves and how it's different from the standard surgical approach I'd otherwise receive?
2Since this trial is listed as Phase NA, which sometimes means it's a very early or first-in-human type study, what does that mean for how much is already known about whether this technique is safe and effective?
3The trial is specifically trying to reduce the chance of the hematoma coming back after surgery — how does my own personal risk of recurrence compare to the average patient, and does that affect whether this kind of study might or might not be worth discussing for my situation?
4What would my experience actually look like if I were to participate — would the plasma treatment happen during the same surgery I'd already need, or would it require additional procedures or extra hospital time beyond standard care?
5If I don't participate in this trial, what is the standard surgical treatment for chronic subdural hematoma, and are there other established ways my care team would try to lower my risk of the blood collection coming back?
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.