Artery Embolization for Subdural Hematoma

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?

Endovascular middle meningeal artery (MMA) embolization is an emerging treatment for chronic subdural hematoma (cSDH). There is preliminary data to suggest that this minimally invasive therapy may be more efficacious and equally as safe compared to conventional, more invasive surgery. This study seeks to assess the safety and efficacy of middle meningeal artery embolization for chronic subdural hematoma as an adjunct to standard treatments, which include medical management and surgical evacuation.

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+