Middle Meningeal Artery Embolization for Subdural Hematoma
(EMMA-Can Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Manitoba
Disqualifiers: Severe renal dysfunction, pregnancy, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
This trial is testing whether an additional procedure can help prevent brain bleeds in patients who have already received usual care. The goal is to see if this extra step can reduce the risk of the brain bleed coming back.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Middle Meningeal Artery Embolization (EMMA) for subdural hematoma?
Is middle meningeal artery embolization generally safe for humans?
How is middle meningeal artery embolization different from other treatments for subdural hematoma?
Middle meningeal artery embolization is a unique, minimally invasive treatment for subdural hematomas that involves blocking the blood supply to the affected area, which can help reduce the hematoma without the need for traditional surgery. This approach is particularly beneficial for patients who have chronic subdural hematomas that do not require immediate surgical evacuation.12589
Research Team
JJ
Jai JS Shankar, MD
Principal Investigator
University of Manitoba
Eligibility Criteria
This trial is for patients with chronic subdural hematoma (CSDH) who can function independently (Modified Rankin Scale ≤2), have a CT scan that allows vascular access for the procedure, and symptoms like headache or cognitive issues due to CSDH. It's not for those with CSDH from conditions like tumors, severe kidney problems, pregnancy, or life expectancy under 6 months.Inclusion Criteria
I can carry out all my usual duties with slight disability.
I need surgery for a brain condition causing symptoms like headaches or seizures.
A head and neck CT scan shows safe blood vessel access for the EMMA procedure and does not have any risky anatomical differences.
Exclusion Criteria
If informed consent can not be obtained from the patients or their substitute decision makers.
You have a specific type of bleeding in the brain that can be seen on a CT scan.
My chronic subdural hematoma is likely due to another brain condition.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive standard of care treatment (surgical drainage and/or medical management) with or without EMMA
1 week
In-person visits for treatment and EMMA procedure
Follow-up
Participants are monitored for recurrence of CSDH and peri-procedural complications
90 days
Follow-up visits at discharge, 30 days, and 90 days
Treatment Details
Interventions
- EMMA (Vascular Embolization Agent)
Trial OverviewThe EMMA-Can study tests if adding embolization of the middle meningeal artery (EMMA) to standard treatments reduces recurrence in CSDH patients. Participants are randomly chosen to receive either just standard care or standard care plus EMMA.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Interventional ArmExperimental Treatment1 Intervention
Patients randomized to the interventional arm will undergo institutional standard of care treatment (surgical drainage and/or medical management for the CSDH as per the standard of care in the institution. These patients will then undergo EMMA within 48 hours after finishing the surgical drainage. The embolic agent and use of general anesthesia vs conscious sedation will be left to operators' preference and the institutional protocol. All patients will be followed as per the institutional standard of the care. Any peri-procedural complications and change in clinical status will be recorded.
Group II: Control ArmActive Control1 Intervention
Patients randomized to the control arm will undergo institutional standard of care treatment (surgical drainage and/or medical management for the CSDH.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of ManitobaWinnipeg, Canada
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Who Is Running the Clinical Trial?
University of Manitoba
Lead Sponsor
Trials
628
Patients Recruited
209,000+
Findings from Research
Embolization of the Middle Meningeal Artery (EMMA) effectively controls the progression of Chronic Subdural Haematoma (CSDH) in 91.1-100% of patients, with a very low treatment failure rate of 0-4.1% when used as the primary treatment.
EMMA significantly reduces the risk of recurrence in patients who have undergone surgery for CSDH, with recurrence rates of 1.4-8.9% compared to 10-20% in traditional surgical cases, and it can be performed safely under local anesthesia.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A systematic review of middle meningeal artery embolization for minimally symptomatic chronic subdural haematomas that do not require immediate evacuation.Rojas-Villabona, A., Mohamed, S., Kennion, O., et al.[2023]
Middle meningeal artery embolization is increasingly recognized as a primary treatment for chronic subdural hematomas, with a growing body of literature supporting its use.
The authors present a case series of 11 patients undergoing this procedure, contributing to the understanding of its advantages and technical aspects in the context of existing studies.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
[Middle meningeal artery embolization for chronic subdural haematoma. Case series and literature review].Stanishevskiy, AV., Babichev, KN., Vinogradov, EV., et al.[2021]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Safety and Effectiveness of Embolization for Chronic Subdural Hematoma: Systematic Review and Case Series.Waqas, M., Vakhari, K., Weimer, PV., et al.[2020]
Embolization of the middle meningeal artery (EMMA) for treating chronic subdural hematoma (CSDH) showed no periprocedural complications in a study of 19 patients, indicating a safe profile for this new treatment.
The newly developed grading scale for assessing EMMA demonstrated substantial inter-rater reliability (Kappa = 0.74), suggesting it can be reliably used in clinical practice to evaluate the extent of the procedure.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Grading Embolization of Middle Meningeal Artery for Chronic Subdural Hematoma.Jai, S., Zul, K.[2023]
Middle meningeal artery embolization is a safe and effective treatment for chronic subdural hematomas, showing a low recurrence rate of 4.1% and a reoperation rate of 4.2% among 382 patients studied.
Using Onyx as the embolic agent resulted in the lowest rates of recurrence and complications, while a combination of polyvinyl alcohol and coils led to the best overall clinical outcomes, suggesting that the choice of embolic agent can significantly impact treatment success.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Embolic Agent Choice in Middle Meningeal Artery Embolization as Primary or Adjunct Treatment for Chronic Subdural Hematoma: A Systematic Review and Meta-analysis.Ku, JC., Dmytriw, AA., Essibayi, MA., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Onyx Versus Particles for Middle Meningeal Artery Embolization in Chronic Subdural Hematoma.Shehabeldin, M., Amllay, A., Jabre, R., et al.[2023]
A study of 116 patients undergoing middle meningeal artery embolization for chronic subdural hematoma found that both liquid and particle embolic materials are equally safe and effective, with no significant differences in radiation dose or procedure duration.
Both embolization methods resulted in similar reductions in hematoma size after approximately one month, indicating that either approach can be used effectively in clinical practice without increased risk.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Outcomes of Particle versus Liquid Embolic Materials Used in Middle Meningeal Artery Embolization for the Treatment of Chronic Subdural Hematoma.Krothapalli, N., Patel, S., Fayad, M., et al.[2023]
In a study of 61 patients with recurrent subdural hematoma, MMA embolization using diluted n-butyl cyanoacrylate (n-BCA) achieved complete obliteration of the targeted arteries in 100% of cases, demonstrating high efficacy in preventing further bleeding.
The procedure showed a low complication rate, with only 5% of patients experiencing recurrence of subdural hematoma and minimal risks of serious side effects such as cranial nerve palsy or stroke.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Middle Meningeal Artery Embolization for Chronic Subdural Hematoma Using N-Butyl Cyanoacrylate With D5W Push Technique.Majidi, S., Matsoukas, S., De Leacy, RA., et al.[2022]
MMA embolization is a safe and effective minimally invasive treatment for chronic subdural hematomas (cSDH), with a median reduction of 77.5% in hematoma size and a 72.8% rate of over 50% improvement in imaging results after the procedure.
Out of 144 patients treated, only 13.8% required retreatment for recurrent issues, and complications were low at 2.8%, indicating a favorable safety profile for this intervention.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Middle meningeal artery embolization without surgical evacuation for chronic subdural hematoma: a single-center experience of 209 cases.Orscelik, A., Senol, YC., Bilgin, C., et al.[2023]
References
A systematic review of middle meningeal artery embolization for minimally symptomatic chronic subdural haematomas that do not require immediate evacuation. [2023]
[Middle meningeal artery embolization for chronic subdural haematoma. Case series and literature review]. [2021]
Safety and Effectiveness of Embolization for Chronic Subdural Hematoma: Systematic Review and Case Series. [2020]
Grading Embolization of Middle Meningeal Artery for Chronic Subdural Hematoma. [2023]
Embolic Agent Choice in Middle Meningeal Artery Embolization as Primary or Adjunct Treatment for Chronic Subdural Hematoma: A Systematic Review and Meta-analysis. [2023]
Onyx Versus Particles for Middle Meningeal Artery Embolization in Chronic Subdural Hematoma. [2023]
Outcomes of Particle versus Liquid Embolic Materials Used in Middle Meningeal Artery Embolization for the Treatment of Chronic Subdural Hematoma. [2023]
Middle Meningeal Artery Embolization for Chronic Subdural Hematoma Using N-Butyl Cyanoacrylate With D5W Push Technique. [2022]
Middle meningeal artery embolization without surgical evacuation for chronic subdural hematoma: a single-center experience of 209 cases. [2023]