Subdural Hematoma > Middle Meningeal Artery Embolization

Middle Meningeal Artery Embolization for Subdural Hematoma (EMMA-Can Trial)

Recruiting in Palo Alto (17 mi)

Overseen By Jai JS Shankar, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Manitoba

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?

Research shows that Middle Meningeal Artery Embolization (EMMA) is becoming a popular and minimally invasive treatment for chronic subdural hematomas, with several studies and reviews indicating its potential benefits and safety.

^{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 procedure for treating chronic subdural hematoma, with early evidence supporting its safety in humans.

^{1 3 4 6 7}

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.

^{1 2 5 8 9}

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.

Exclusion Criteria

I am not pregnant and do not have severe kidney problems.

Participant Groups

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.

Group I: Interventional Arm Experimental Treatment 1 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 Arm Active Control 1 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 nearby Select from list below to view details:

University of Manitoba Winnipeg, Canada

Who is running the clinical trial?

University of Manitoba Lead Sponsor

References

1. Netherlands 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. [2023] Embolization of the Middle Meningeal Artery (EMMA) is an emerging treatment option for patients with Chronic Subdural Haematoma (CSDH).

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

[Middle meningeal artery embolization for chronic subdural haematoma. Case series and literature review]. [2021] Middle meningeal artery embolization as primary method for treatment of chronic subdural hematomas became more popular in past decade. There are few large case series (>150 patients) and literature reviews characterizing advantages and drawbacks of endovascular treatment and technical features of surgeries. In this manuscript, the authors report 11 patients with chronic subdural hematoma scheduled for middle meningeal artery embolization and review the literature data on this issue.

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

Safety and Effectiveness of Embolization for Chronic Subdural Hematoma: Systematic Review and Case Series. [2020] Embolization of the middle meningeal artery (MMA) has emerged as a minimally invasive means of managing subdural hematoma. The purpose of this study was to systematically review the literature on the safety and effectiveness of this treatment and to share our clinical experience.

4. England pubmed.ncbi.nlm.nih.gov

Grading Embolization of Middle Meningeal Artery for Chronic Subdural Hematoma. [2023] Embolization of middle meningeal artery (EMMA) is a relatively new treatment for chronic subdural hematoma (CSDH). To date, an objective method that assesses or describes the extent of EMMA for the treatment of CSDH does not exist. Recently, the concept of a novel grading scale for EMMA in patients with CSDH has emerged. However, this has not been applied to a clinical case setting and inter-rater reliability has not yet been studied. The purpose of this study was to validate the grading scale in clinical practice and to assess for inter-rater reliability.

5. 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] Middle meningeal artery embolization is an emerging treatment option for chronic subdural hematomas.

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

Onyx Versus Particles for Middle Meningeal Artery Embolization in Chronic Subdural Hematoma. [2023] Middle meningeal artery (MMA) embolization has recently emerged as a treatment option for chronic subdural hematoma (cSDH). It is considered a simple and potentially safe endovascular procedure.

7. 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] Early evidence suggests that middle meningeal artery (MMA) embolization is an efficacious minimally invasive neuroendovascular technique for the management of chronic subdural hematoma (cSDH). Particle and liquid embolic materials are commonly used to embolize the MMA; however, studies comparing the safety and outcomes between these 2 materials are limited.

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

Middle Meningeal Artery Embolization for Chronic Subdural Hematoma Using N-Butyl Cyanoacrylate With D5W Push Technique. [2022] Middle meningeal artery (MMA) embolization has been recognized as a promising treatment for patients with subdural hematoma (SDH).

9. 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] Middle meningeal artery (MMA) embolization is a minimally invasive treatment option for new and recurrent chronic subdural hematomas (cSDH).