Artery Embolization for Subdural Hematoma

No longer recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Significant midline shift, Carotid stenosis, Kidney failure, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 26

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for chronic subdural hematoma, a type of blood clot on the brain. The study examines a less invasive procedure called middle meningeal artery embolization, which blocks blood flow in specific brain arteries, to determine if it is as safe and effective as traditional surgery. The trial includes different groups: one will undergo only this new procedure, another will receive both the procedure and surgery, and others will serve as historical comparisons. Suitable candidates have been diagnosed with a chronic subdural hematoma and experience mild symptoms like headaches or slight confusion.

As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for the trial?

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 prior data suggests that middle meningeal artery embolization is safe for chronic subdural hematoma?

Research has shown that middle meningeal artery embolization, a procedure that blocks a blood vessel to stop bleeding, is a safe treatment for chronic subdural hematoma, a type of brain bleed. Studies found the procedure succeeded in all patients, with very few complications. In one study, only 1.6% of patients experienced unintended effects on nearby blood vessels. Other research indicates this treatment is not only effective but also well-tolerated, even in older patients. Overall, the evidence suggests that middle meningeal artery embolization is a safe option for treating chronic subdural hematoma. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about middle meningeal artery embolization for treating subdural hematoma because it offers a minimally invasive alternative to traditional surgery. Unlike standard options that often involve surgical evacuation of the hematoma, embolization works by blocking blood flow to the affected area, potentially preventing further bleeding with fewer risks and faster recovery times. This approach could be particularly beneficial for patients who are not ideal candidates for surgery due to other health issues. By exploring both embolization alone and in combination with standard evacuation, researchers hope to establish more effective and safer treatment protocols for managing subdural hematomas.

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

Research has shown that middle meningeal artery embolization (MMAE) effectively treats chronic subdural hematoma (cSDH), a type of brain bleed. In this trial, participants may receive MMAE alone or combined with standard evacuation. Studies indicate that MMAE, whether used alone or with other treatments, results in fewer recurrences of the hematoma compared to surgery alone. Specifically, fewer patients require a second procedure when treated with MMAE. Additionally, MMAE leads to fewer complications than traditional surgery. While some patients might still need further treatment, the overall safety remains good. ^{1 5 6 7 8}

Who Is on the Research Team?

Joshua W Osbun, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with a new or recurring chronic subdural hematoma (cSDH) who have minimal symptoms like headaches or mild neurological issues. It's not for those needing urgent decompression, with over 50% carotid stenosis, kidney failure, tricky anatomy for angiography, or hematomas due to other conditions.

Inclusion Criteria

I am 18 or older and being treated for a new chronic subdural hematoma.

I only have mild symptoms like headaches or slight changes in thinking or movement.

I am 18 or older and had surgery for a brain bleed but still have some bleeding or it came back.

Exclusion Criteria

My carotid artery is more than half blocked.

I have a recent brain bleed under its outer covering.

I cannot undergo angiography due to kidney issues or unique body structure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo middle meningeal artery embolization, a minimally invasive angiography procedure

1 week

1 visit (in-person)

Observation

Participants are observed for 24-48 hours on a neurological care unit post-procedure

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up CT scans and neurologic assessments

90 days

Multiple visits (in-person) at 24 hours, 7-10 days, 30 days, and 90 days post-procedure

What Are the Treatments Tested in This Trial?

Interventions

• Middle Meningeal Artery Embolization

Trial Overview The study tests middle meningeal artery embolization using PVA particles as an add-on to standard treatments like medical management and surgical drainage in patients with cSDH. The goal is to see if this less invasive method is safer and more effective.

How Is the Trial Designed?

Group I: Surgical Patients Experimental Treatment 1 Intervention

Historical control of patients receiving standard surgery alone

Group II: Medical Management Experimental Treatment 0 Interventions

Historical control of medically managed patients

Group III: Embolization Only Experimental Treatment 1 Intervention

Medically managed patient receives middle meningeal artery embolization

Group IV: Embolization + Evacuation Experimental Treatment 2 Interventions

Participant receives standard of care evacuation and then undergoes MMA embolization

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

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

Middle meningeal artery embolization for chronic subdural ... The most common primary outcome is recurrence (47.8%, N = 11), either radiologically, or requiring a second surgery. Inclusion criteria, ...

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. thejns.org thejns.org/focus/view/journals/neurosurg-focus/59/4/article-pE8.xml

Comparative effectiveness of standalone middle meningeal ... The primary outcome was reintervention due to hematoma recurrence. Secondary outcomes included the hospital length of stay (LOS), new neurological deficits, and ...

6. ahajournals.org ahajournals.org/doi/10.1161/SVIN.125.001814

Consensus Statement on Middle Meningeal Artery ... Embolization was successful in all 185 patients (100%), with reflux to nontarget vessels in 1.6%. Proximal and distal MMA occlusion occurred in ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39681110/

Efficacy and Safety of Middle Meningeal Artery ... Conclusion: MMA embolization in CSDH management is a safe and effective approach for CSDH. Keywords: Best medical management; Chronic subdural ...

8. jnis.bmj.com jnis.bmj.com/content/17/Suppl_1/A24.3

O-029 Middle meningeal artery embolization as a ... Conclusion MMAE shows promise as a safe, effective treatment for acute SDH, with high procedural success and favorable outcomes. Further research is warranted ...