Embolization vs Surgery for Subdural Hematoma

(CHESS Trial)

Recruiting at 32 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

Trial Summary

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 middle meningeal artery embolization (MMAE) safe for treating chronic subdural hematomas?

Middle meningeal artery embolization (MMAE) is considered a promising and minimally invasive treatment for chronic subdural hematomas, with studies suggesting it is generally safe for use in humans. ^{1 2 3 4 5}

How is the treatment of Middle Meningeal Artery Embolization (MMAE) different from other treatments for subdural hematoma?

Middle Meningeal Artery Embolization (MMAE) is a novel, minimally invasive treatment for subdural hematomas that can be used alone or alongside surgery. Unlike traditional surgery, MMAE aims to prevent the recurrence of hematomas by blocking the blood supply to the affected area, potentially reducing the need for repeat surgeries. ^{2 3 4 5 6}

What is the purpose of this trial?

The goal of this clinical trial is to test in moderately symptomatic chronic subdural hematoma (CSDH) patients if middle meningeal artery embolization (MMAE) can be used as an alternative to conventional open surgery. The main questions it aims to answer are: * Compared to open conventional surgery, does MMAE reduce the need for rescue surgery or deaths? * What is the safety of MMAE and conventional open surgery in these patients? Participants will be asked to: * Share their medical history and undergo physical examinations * Have blood drawn * Have CT scans of the head * Answer questionnaires * Undergo MMAE or conventional open surgery * Provide information about possible adverse events Researchers will compare participants in the MMAE group with those in the conventional open surgery group to see if there is a reduced need for rescue surgery or deaths and evaluate safety.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

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

Middle meningeal artery embolization for treatment of chronic subdural hematomas: does selection of embolized branches affect outcomes? [2023]

2. England 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. [2023]

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

Trends and Outcomes of Primary, Rescue, and Adjunct Middle Meningeal Artery Embolization for Chronic Subdural Hematomas. [2022]

4. United States 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. [2023]

5. United States 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. [2023]

6. United States 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. [2023]