Middle Meningeal Artery Embolization for Subdural Hematoma

(EMMA-Can Trial)

Overseen By Jai Shankar, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Disqualifiers: Severe renal dysfunction, pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 30

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new procedure called EMMA (Middle Meningeal Artery Embolization) to determine if it can reduce the recurrence of subdural hematoma, a type of brain bleed. Patients will receive either the usual treatment, which might include surgery, or the usual treatment plus the EMMA procedure. The trial seeks participants with a subdural hematoma causing symptoms like headaches or confusion and at least 10 mm of bleeding visible on a CT scan. The study aims to discover if adding EMMA helps prevent the condition from returning. As an unphased trial, it offers patients the chance to contribute to groundbreaking research that could enhance future treatment options.

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 prior data suggests that the middle meningeal artery embolization is safe for treating chronic subdural hematoma?

Research has shown that middle meningeal artery embolization (EMMA) is generally safe for treating chronic subdural hematoma (CSDH). In one study, the procedure succeeded in all 185 patients, with only 1.6% experiencing minor issues. Another study found that EMMA is safe and effective, even for older adults. However, one study noted that 8% of patients who underwent the procedure died within 180 days, compared to 5% in the group that did not have the procedure, though not all deaths were related to EMMA. Overall, EMMA appears well-tolerated with a low risk of serious problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for subdural hematoma, like surgical drainage and medical management, focus on directly removing or managing the blood collection. However, researchers are excited about Middle Meningeal Artery Embolization (EMMA) because it offers a different approach by targeting the blood supply itself. EMMA involves blocking the middle meningeal artery, which can reduce the chance of re-bleeding and potentially speed up recovery. This procedure is less invasive than traditional surgery and could offer a quicker, safer alternative for patients.

What evidence suggests that EMMA is effective for chronic subdural hematoma?

Research has shown that middle meningeal artery embolization (EMMA) can effectively treat chronic subdural hematomas (CSDH), a type of brain bleed. In this trial, participants in the interventional arm will undergo EMMA alongside standard care. Studies indicate that EMMA outperforms traditional treatments alone, with fewer patients needing additional surgeries. Specifically, one study found that only 5.9% of patients required another procedure after EMMA. Furthermore, EMMA has proven safe for older adults, even those in their 90s. Overall, this treatment shows promise in reducing the recurrence of CSDH. ^{1 4 5 6 7}

Who Is on the Research Team?

Jai JS Shankar, MD

Principal Investigator

University of Manitoba

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• EMMA

Trial Overview

The 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.

How Is the Trial Designed?

Group I: Interventional Arm Experimental Treatment 1 Intervention

Patients randomized to the interventional arm will undergo institutional standard of care treatment (surgical drainage) for the CSDH followed by EMMA within 72 hours of surgical drainage. The embolization will be done using a liquid embolic agent (Onyx) and will be done under a general anesthesia or conscious sedation as per the operator's preference. 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 Arm Active Control 1 Intervention

Patients randomized to the control arm will undergo institutional standard of care treatment (surgical drainage) for the CSDH.

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

In a study of 97 patients undergoing middle meningeal artery embolization for chronic subdural hematoma, both onyx and polyvinyl alcohol (PVA) were found to be safe and effective embolic agents, with no significant differences in failure rates or need for rescue surgery.

However, the PVA group showed a significantly smaller hematoma thickness at late follow-up compared to the onyx group, suggesting a potential advantage in long-term outcomes.

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]

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]

MMA embolization is a safe and effective treatment for chronic subdural hematoma (CSDH), with a low recurrence rate of 3.6% and no reported complications in a review of 15 studies involving 193 procedures.

In our clinical experience with 8 patients treated using Onyx, all experienced symptom relief and significant reduction in hematoma size, further supporting the efficacy of this minimally invasive approach.

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12152056/

Middle meningeal artery embolization for chronic subdural ...

The most common primary outcome is recurrence (47.8%, N = 11), either radiologically, or requiring a second surgery. Inclusion criteria, ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0303846725000307

Middle meningeal artery embolization for chronic subdural ...

MMA embolization is safe and effective in the nonagenarian population. · MMA embolization may be applied as primary or adjunctive treatment. · Multiple sedation/ ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37830938/

Comparative study on clinical outcomes and cost ...

Conclusion: MMAE is more effective in treating cSDH than conventional treatment. Based on real-world data, though MMAE incurs higher overall ...

4.

ahajournals.org

ahajournals.org/doi/10.1161/SVIN.04.suppl_1.300

Abstract 300: Incidence and Outcomes following Middle ...

Following MMAE for cSDH, 13.9% of patients died within a year. While only 5.9% have required re‐embolization so far, the cSDH patients had poor ...

5.

nejm.org

nejm.org/doi/abs/10.1056/NEJMoa2409845

Embolization of the Middle Meningeal Artery for Chronic ...

The primary efficacy outcome was a composite of the following events: recurrent or residual chronic subdural hematoma (measuring >10 mm) at 180 ...

6.

ahajournals.org

ahajournals.org/doi/10.1161/SVIN.125.001814

Consensus Statement on Middle Meningeal Artery ...

Embolization was successful in all 185 patients (100%), with reflux to nontarget vessels in 1.6%. Proximal and distal MMA occlusion occurred in ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37828746/

Safety and efficacy comparison of embolic agents for ...

A systematic literature review and meta-analysis was performed to evaluate the impact of embolic agents on outcomes for middle meningeal artery (MMA) ...