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

Trial Summary

What is the purpose of this trial?

EMMA-Can is a prospective cohort study to assess the safety and effectiveness of MMA-embolization for the treatment of CSDH. Hypothesis- EMMA reduces the recurrence rate of SDH with or without concomitant surgical evacuation.

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 data supports the effectiveness of the treatment embolization of the middle meningeal artery for subdural hematoma?

Research shows that embolization of the middle meningeal artery is emerging as an effective and minimally invasive treatment for subdural hematomas, with studies indicating its potential to prevent the maintenance of these blood collections in the brain. ^{1 2 3 4 5}

Is middle meningeal artery embolization generally safe for humans?

Middle meningeal artery embolization is considered a minimally invasive and potentially safe method for treating chronic subdural hematoma, with studies suggesting it is a promising treatment option. ^{5 6 7 8 9}

How is middle meningeal artery embolization different from other treatments for subdural hematoma?

Middle meningeal artery embolization is a minimally invasive treatment that involves blocking the blood supply to the area of the brain affected by the hematoma, which can help reduce its size and prevent recurrence. Unlike traditional surgical methods that require opening the skull, this procedure is done through a small incision, making it less invasive and potentially safer for patients. ^{3 4 5 9 10}

Research Team

Jai Shankar, MD

Principal Investigator

University of Manitoba

Eligibility Criteria

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

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

When informed consent is not possible

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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

1. United States pubmed.ncbi.nlm.nih.gov

Predictors of Subsequent Intervention After Middle Meningeal Artery Embolization for Treatment of Subdural Hematoma: A Nationwide Analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

DynaCT Enhancement of Subdural Membranes After Middle Meningeal Artery Embolization: Insights into Pathophysiology. [2020]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Middle meningeal artery embolization for chronic subdural haematoma. Case series and literature review]. [2021]

4. United States 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Safety and Effectiveness of Embolization for Chronic Subdural Hematoma: Systematic Review and Case Series. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Middle Meningeal Artery Embolization Versus Conventional Treatment of Chronic Subdural Hematomas. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Middle meningeal artery embolization for chronic subdural hematoma: an institutional technical analysis. [2021]

8. United States 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Middle Meningeal Artery Embolization for Chronic Subdural Hematoma Using N-Butyl Cyanoacrylate With D5W Push Technique. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Middle meningeal artery embolization without surgical evacuation for chronic subdural hematoma: a single-center experience of 209 cases. [2023]