Middle Meningeal Artery Embolization for Subdural Hematoma

(EMMA-Can Trial)

Overseen By Susan Alcock, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Disqualifiers: Allergy to embolic agent, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called embolization of the middle meningeal artery for individuals with a subdural hematoma, a collection of blood on the brain's surface. The goal is to determine if this treatment can safely and effectively reduce the recurrence of the hematoma. Participants will receive this treatment to evaluate its effectiveness with or without additional surgery. Suitable candidates for this trial include those visiting an emergency room or neurosurgical clinic with a suspected subdural hematoma. As an unphased trial, this study provides a unique opportunity to explore a potentially effective treatment option for subdural hematoma.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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

Research has shown that treating chronic subdural hematoma (CSDH), a type of brain bleed, with embolization of the middle meningeal artery (MMA) is generally safe. In one study conducted at a single center, patients who underwent MMA embolization did not experience more side effects than those receiving other treatments, indicating the procedure is well-tolerated. Furthermore, a study involving multiple centers found that patients treated with MMA embolization had positive outcomes, with no increase in treatment failure compared to standard methods. These findings suggest that MMA embolization is a promising and safe option for managing CSDH. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for chronic subdural hematoma, like surgical drainage or craniotomy, involve invasive procedures to physically remove the blood buildup. But embolization of the middle meningeal artery works differently by blocking the blood flow to the area, which can help the body absorb the hematoma naturally without the need for surgery. Researchers are excited about this method because it offers a less invasive alternative that could reduce recovery times and lower the risk of complications associated with traditional surgical approaches.

What evidence suggests that embolization of the middle meningeal artery is effective for subdural hematoma?

Research has shown that blocking the middle meningeal artery (MMA) effectively treats chronic subdural hematoma (CSDH). Studies have found this treatment works approximately 92.9% of the time and has a low complication rate of 7.1%, making it a relatively safe option. Additionally, MMA embolization is linked to fewer recurrences and complications compared to surgery alone. In this trial, all participants will undergo embolization of the middle meningeal artery as the main treatment, offering flexibility in managing the condition. ^{1 4 6 7 8}

Who Is on the Research Team?

Jai Shankar, MD

Principal Investigator

University of Manitoba

Are You a Good Fit for This Trial?

The EMMA Can trial is for patients who arrive at the emergency room or neurosurgical clinic with a subdural hematoma, which is bleeding on the brain's surface. Participants must be able to give informed consent and not have allergies to the embolic agent used in treatment.

Inclusion Criteria

I have a subdural hematoma and am seeking emergency or outpatient neurosurgical care.

Exclusion Criteria

When informed consent is not possible

You are allergic to the liquid used to block blood vessels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo embolization of the Middle Meningeal Artery for Subdural Hematoma

1 day

1 visit (in-person)

Follow-up

Participants are monitored for recurrence of CSDH and peri-procedural morbidity and mortality

6 months

3 visits (in-person) at 1, 3, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Embolization of the middle meningeal artery

Trial Overview This study tests if blocking blood flow to certain arteries in the brain (middle meningeal artery embolization) can reduce recurrence of subdural hematomas, with or without surgery. It aims to improve patient outcomes by preventing further bleeding.

How Is the Trial Designed?

Group I: Embolization of Middle Meningeal Artery for Subdural Hematoma Experimental Treatment 1 Intervention

All patients with CSDH will undergo embolization of Middle Meningeal artery

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Published Research Related to This Trial

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]

In a study comparing middle meningeal artery (MMA) embolization to conventional treatment for chronic subdural hematoma (cSDH), both methods showed similar safety profiles with no significant differences in complications or clinical improvement rates among 25 matched pairs of patients.

While MMA embolization showed a trend towards lower recurrence and mortality rates, conventional treatment resulted in significantly higher rates of radiographic improvement, suggesting that while MMA embolization is safe, traditional surgery may be more effective in improving imaging outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Middle Meningeal Artery Embolization Versus Conventional Treatment of Chronic Subdural Hematomas. Enriquez-Marulanda, A., Gomez-Paz, S., Salem, MM., et al.[2022]

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]

In a study of 35 patients undergoing middle meningeal artery (MMA) embolization for chronic subdural hematoma (cSDH), the procedure demonstrated a high safety and efficacy profile, with 63% of cases achieving complete resolution of the hematoma.

Embolizing both the anterior and posterior branches of the MMA significantly increased the likelihood of complete resolution (76% success) compared to single-branch embolization (33% success), suggesting that targeting multiple branches may enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Middle meningeal artery embolization for chronic subdural hematoma: an institutional technical analysis. Catapano, JS., Ducruet, AF., Nguyen, CL., et al.[2021]

In a study of 322 patients who underwent middle meningeal artery (MMA) embolization for subdural hematomas (SDHs), 17.1% required additional surgical interventions within 5 years, indicating that while MMA embolization is effective, there is still a risk of future complications.

Patients using factor Xa inhibitors were found to have a higher likelihood of needing subsequent interventions after MMA embolization, suggesting that this medication may be a significant risk factor for complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Subsequent Intervention After Middle Meningeal Artery Embolization for Treatment of Subdural Hematoma: A Nationwide Analysis. Fuentes, AM., Khalid, SI., Mehta, AI.[2022]

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]

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]

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]

In a study of 27 patients with subdural hematomas who underwent middle meningeal artery (MMA) embolization, there was an impressive average reduction of 87% in hematoma volume after treatment, indicating the efficacy of this intervention.

No complications or need for further drainage procedures were reported post-embolization, suggesting that MMA embolization is a safe method for managing subdural hematomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DynaCT Enhancement of Subdural Membranes After Middle Meningeal Artery Embolization: Insights into Pathophysiology. Mureb, MC., Kondziolka, D., Shapiro, M., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39565980/

Embolization of the Middle Meningeal Artery for Chronic ... The primary safety outcome was a composite of major disabling stroke or death from any cause within 30 days. Results: Among 310 enrolled ...

2. 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 ...

3. 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/ ...

4. jnis.bmj.com jnis.bmj.com/content/17/Suppl_1/A237.2

E-212 Comparative outcomes of middle meningeal artery ... MMAE, whether used alone or as an adjunct, is associated with significantly lower recurrence and fewer complications than surgery alone.

5. italjmed.org italjmed.org/ijm/article/view/1759/1691

Outcomes of middle meningeal artery embolization for ... Our study found that the success rate of MMA embolization for treating cSDH was 92.9%, with a complication rate of 7.1%.

6. ahajournals.org ahajournals.org/doi/10.1161/SVIN.04.suppl_1.177

Abstract 177: A Single‐Center Retrospective Safety ... Abstract 177: A Single‐Center Retrospective Safety Review of Middle Meningeal Artery (MMA) Embolization for Management of Chronic Subdural ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06181994

Middle Meningeal Artery Embolization (MMAE) Outcomes ... This multi-center retrospective cohort study aims to investigate the real-world outcomes of chronic subdural hematoma treated with MMAE, including clinical ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40210750/

Middle meningeal artery embolization for chronic subdural ... Functional outcomes at 90 days were not significantly different between groups. Similarly, adverse events and mortality rates were comparable ...