Embolization vs Surgery for Subdural Hematoma

(CHESS Trial)

Recruiting at 35 trial locations

Overseen By Roberto Garcia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Medical Branch, Galveston

Must not be taking: Antiplatelets, OACs, Tranexamic acid

Disqualifiers: Vascular abnormalities, Tumors, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 week

520 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if middle meningeal artery embolization (MMAE) offers a safer and more effective alternative to traditional open surgery for treating chronic subdural hematoma (CSDH), a type of brain bleed. Researchers are comparing MMAE with open surgery to assess whether it reduces the need for additional surgeries or decreases the risk of death. The trial seeks participants diagnosed with CSDH who experience noticeable symptoms affecting their daily life. As an unphased trial, this study provides participants the opportunity to contribute to groundbreaking research that could enhance treatment options for CSDH.

Will I have to stop taking my current medications?

The trial requires participants to stop taking all antiplatelet agents or oral anticoagulants (OACs) for the first 7 days after randomization.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Middle Meningeal Artery Embolization (MMAE) is generally safe for treating chronic subdural hematoma (CSDH). Studies on MMAE have not linked the treatment to any deaths caused by the procedure or its materials. In one safety study, 8% of patients who underwent MMAE died within 180 days, but these deaths were not directly related to the treatment.

MMAE appears to be a promising option for patients, even those in their 90s, indicating it can be a safe and effective treatment. While some patients died from various causes, these were not directly connected to the MMAE procedure. Overall, evidence suggests MMAE is well-tolerated with careful monitoring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard surgical treatments for subdural hematoma, which typically involve craniotomy or burr holes, Middle Meningeal Artery Embolization (MMAE) offers a minimally invasive alternative. This technique works by blocking off the artery that supplies blood to the hematoma, reducing the risk of recurrence and potentially leading to quicker recovery times. Researchers are excited about MMAE because it could offer a safer, less invasive option with fewer complications than traditional surgery, which is especially beneficial for patients who may not be ideal candidates for more invasive procedures.

What evidence suggests that this trial's treatments could be effective for chronic subdural hematoma?

This trial will compare two treatments for chronic subdural hematoma (CSDH): conventional surgery and middle meningeal artery embolization (MMAE). Research has shown that MMAE effectively treats CSDH, a type of brain bleed. Studies have found that MMAE leads to fewer repeat cases and complications than traditional surgery. Specifically, one study noted that patients who underwent MMAE required fewer additional procedures. Another study confirmed that MMAE is safe and effective for these brain bleeds. Although some patients might still need further treatment, the overall results with MMAE are encouraging. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients with moderately symptomatic chronic subdural hematoma (CSDH), a type of blood clot under the skull. Participants should be able to provide their medical history, undergo physical exams, have blood tests and CT scans, answer questionnaires, and receive either MMAE or conventional surgery.

Inclusion Criteria

I am between 40 and 90 years old.

Qualifying baseline head CT performed within the 7 days prior to randomization

CSDH at least 2/3 isodense or hypodense, verified on axial CT slice used to measure the thickness of the qualifying CSDH

Exclusion Criteria

Known contraindications to angiography

I have a subdural hematoma in the upper part of my brain.

I had brain surgery for a blood clot that was larger than 7 cm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo either middle meningeal artery embolization (MMAE) or conventional open surgery

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments for rescue surgery needs or deaths

26-30 weeks

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Conventional Surgery
• Middle Meningeal Artery Embolization (MMAE)

Trial Overview

The study compares two treatments for CSDH: Middle Meningeal Artery Embolization (MMAE) versus conventional open surgery. It aims to see if MMAE can reduce the need for additional rescue surgeries or lower death rates compared to traditional surgery.

How Is the Trial Designed?

Group I: Middle Menningeal Artery Embolization (MMAE) Experimental Treatment 1 Intervention

Group II: Conventional Surgery (Craniotomy or Burr Holes) Active Control 1 Intervention

Conventional Surgery is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Conventional Surgery for:

• Various surgical conditions

Approved in United States as Conventional Surgery for:

• Various surgical conditions

Approved in Canada as Conventional Surgery for:

• Various surgical conditions

Approved in Japan as Conventional Surgery for:

• Various surgical conditions

Approved in China as Conventional Surgery for:

• Various surgical conditions

Approved in Switzerland as Conventional Surgery for:

• Various surgical conditions

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

In a study of 94 chronic subdural hematomas (cSDH) treated with middle meningeal artery (MMA) embolization, different techniques (proximal trunk, distal branches, or both) showed similar effectiveness in reducing hematoma size and the need for rescue surgery.

Embolizing just one branch of the MMA yielded comparable outcomes to embolizing multiple branches, suggesting that targeting any location in the MMA can effectively restrict blood flow and promote spontaneous resolution of the hematoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Middle meningeal artery embolization for treatment of chronic subdural hematomas: does selection of embolized branches affect outcomes? Khorasanizadeh, M., Shutran, M., Garcia, A., et al.[2023]

In a study of 606 patients undergoing middle meningeal artery embolization (MMAE) combined with surgery for chronic subdural hematomas (CSDH), the MMAE group experienced a longer hospital stay (9.87 days) and higher complication rates (8.7%) compared to surgery alone (7.53 days and 5.5% respectively).

Despite the increased costs and complications associated with MMAE, this approach resulted in a significantly lower 30-day readmission rate (4.2% vs 8.0%) compared to surgery alone, suggesting a potential benefit in reducing recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Middle Meningeal Artery Embolization in Adjunction to Surgical Evacuation for Treatment of Subdural Hematomas: A Nationwide Comparison of Outcomes With Isolated Surgical Evacuation. Khorasanizadeh, M., Maroufi, SF., Mukherjee, R., et al.[2023]

In a study of 588 patients with chronic subdural hematomas (cSDHs) who underwent middle meningeal artery embolization (MMAE), standalone MMAE showed similar effectiveness to MMAE combined with surgery, with comparable rates of surgical rescue and radiographic failure.

Both treatment approaches resulted in low recurrence rates and effective outcomes, suggesting that standalone MMAE can be a viable option for select patients with moderately sized cSDHs and mild clinical symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standalone middle meningeal artery embolization versus middle meningeal artery embolization with concurrent surgical evacuation for chronic subdural hematomas: a multicenter propensity score matched analysis of clinical and radiographic outcomes. Chen, H., Salem, MM., Colasurdo, M., et al.[2023]

In a study of 4274 patients with chronic subdural hematomas, middle meningeal artery embolization (MMAE) was found to have a significantly lower need for surgical rescue compared to primary surgery, indicating it may be a more effective initial treatment option.

There were no significant differences in complications such as headache, facial weakness, or mortality between patients treated with primary MMAE, adjunct MMAE, or primary surgery, suggesting that MMAE is a safe alternative for managing cSDH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends and Outcomes of Primary, Rescue, and Adjunct Middle Meningeal Artery Embolization for Chronic Subdural Hematomas. Nia, AM., Srinivasan, VM., Siddiq, F., et al.[2022]

Standalone middle meningeal artery embolization (MMAE) for chronic subdural hematomas (cSDH) resulted in a statistically significant reduction in subdural thickness compared to combined MMAE and surgery, with a follow-up period of 5.4 months for the standalone group versus 2.3 months for the combined group.

The rates of surgical recurrence were similar between standalone MMAE (6.8%) and combined MMAE with surgery (4.6%), suggesting that standalone MMAE may be a viable alternative treatment option for select patients with cSDH, although further studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Middle meningeal artery embolization as standalone treatment versus combined with surgical evacuation for chronic subdural hematomas: systematic review and meta-analysis. Chen, H., Colasurdo, M., Kan, PT.[2023]

In a study comparing 146 patients who underwent open surgery alone to 41 patients who had adjunctive middle meningeal artery embolization (MMAE) after surgery for chronic subdural hematomas (cSDH), the MMAE group showed significantly lower rates of recurrence (7.7% vs 30.8%) and reintervention (3.8% vs 23.1%).

The results suggest that adding MMAE to open surgery is an effective strategy to reduce the risk of cSDH recurrence and the need for further interventions, highlighting its potential as a valuable adjunctive treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced recurrence of chronic subdural hematomas treated with open surgery followed by middle meningeal artery embolization compared to open surgery alone: a propensity score-matched analysis. Salih, M., Shutran, M., Young, M., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

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

Middle meningeal artery embolization for chronic subdural ...

Other studies have been produced concluding MMAE is a safe and effective approach for CSDH, with one using conference abstract data, and using ...

2.

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.

3.

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 ...

4.

sciencedirect.com

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

Middle meningeal artery embolization for chronic subdural ...

We investigated the outcomes of middle meningeal artery embolization (MMAe) as either a primary or adjunctive treatment for cSDH in nonagenarian patients.

5.

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 ...

6.

ahajournals.org

ahajournals.org/doi/10.1161/SVIN.125.001814

Consensus Statement on Middle Meningeal Artery ...

However, 180‐day mortality was 8% with the MMAE group, and 5% with standard treatment, and no death was attributed to MMAE or embolic agent.

7.

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 ...

8.

nejm.org

nejm.org/doi/10.1056/NEJMoa2409845

Embolization of the Middle Meningeal Artery for Chronic ...

Through 180 days, 12 patients (8%) in the embolization group and 9 patients (5%) in the control group had died, with death from neurologic ...