Management of CSDH With or Without EMMA- a Randomized Control Trial (NCT04750200)
Management of Chronic Subdural Hematoma With or Without Embolization of Middle Meningeal Artery in Canada (EMMA-Can)- A Randomized Control Trial.
🩺 Plain-English Summary (8th-Grade Level)
EMMA-Can is a prospective randomized open-label, blinded end point (PROBE) study, that will assess the recurrence risk and safety of embolization of the middle meningeal (EMMA) when added to standard of care treatment (surgical drainage) of chronic subdural hematoma (CSDH) compared to surgical treatment alone.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (10 items).
Location: University of Manitoba — Winnipeg, Manitoba
Age range: 18 Years
🧪 Interventions in This Study
- Embolization of the Middle Meningeal Artery (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- If informed consent cannot be obtained from the patients or their substitute decision makers;
- Patients with bilateral symptomatic CSDH;
- CTA showing persistent communication between branches of middle meningeal artery and that of internal carotid arteries;
- Contraindication to the embolization procedure such as severe renal dysfunction (eGFR\<30), or pregnancy;
- Life expectancy \< 6 months;
- Known allergy to Onyx;
- Acute subdural hematoma with homogenous hyperdensity on CT scan;
- Secondary CSDH that may likely be due to the underlying condition such as a vascular lesion, brain tumor, arachnoid cyst, spontaneous intracranial hypotension or prior craniotomy;
- Patients needing treatment with 2 weeks of dexamethasone or tranexamic acid will be contraindicated in the study patients to avoid confounding.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of Manitoba — Winnipeg, Manitoba
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Chronic Subdural Hematoma
- Middle Meningeal Artery Embolization (MMAE) Outcomes for Chronic Subdural Hematoma (cSDH) — Coral Gables, Florida
- The CHALLENGER Registry — New York, New York
- Assessing Outcomes of Coil Embolization for Unilateral vs Bilateral Chronic Subdural Hematomas — Burlington, Massachusetts
- Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence — Medellín, Antioquia
- Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma — Ocoyoacac, State of Mexico
- Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center — Columbus, Ohio
Explore by condition: All Chronic Subdural Hematoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.