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Artery Embolization for Subdural Hematoma

N/A

Recruiting

Led By Joshua W Osbun, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients 18 years or older undergoing treatment for a new diagnosis of chronic subdural hematoma (cSDH)

Patients 18 years or older who have undergone surgical evacuation of a subdural hematoma and have a significant residual hematoma status post-surgery or who develop a recurrent subdural hematoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure

Awards & highlights

Study Summary

This trial is testing a new, minimally invasive treatment for chronic subdural hematoma (cSDH), which is a build-up of blood around the brain. Early data suggests it may be more effective and just as safe as traditional surgery.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include complications from the embolization procedure such as minor bleeding, infection risk at the catheter site, allergic reaction to materials used during embolization, and possible temporary worsening of neurological symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of patients requiring secondary evacuation surgery (Treatment Efficacy)

Number of patients with recurrent or refractory hematoma (Radiographic resolution)

Secondary outcome measures

Change in NIH Stroke Scale Score (Functional outcome)

Change in modified Rankin Scale (Functional outcome)

Change in size of subdural hematoma

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Embolization OnlyExperimental Treatment1 Intervention

Medically managed patient receives middle meningeal artery embolization

Group II: Embolization + EvacuationExperimental Treatment2 Interventions

Participant receives standard of care evacuation and then undergoes MMA embolization

Group III: Medical ManagementActive Control1 Intervention

Historical control of medically managed patients

Group IV: Surgical PatientsActive Control1 Intervention

Historical control of patients receiving standard surgery alone

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,936 Previous Clinical Trials

2,299,252 Total Patients Enrolled

Joshua W Osbun, MDPrincipal InvestigatorWashington University School of Medicine

Media Library

Drainage of Subdural Hematoma Clinical Trial Eligibility Overview. Trial Name: NCT04065113 — N/A

Subdural Hematoma Research Study Groups: Embolization Only, Embolization + Evacuation, Medical Management, Surgical Patients

Subdural Hematoma Clinical Trial 2023: Drainage of Subdural Hematoma Highlights & Side Effects. Trial Name: NCT04065113 — N/A

Drainage of Subdural Hematoma 2023 Treatment Timeline for Medical Study. Trial Name: NCT04065113 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What goals is this trial seeking to accomplish?

"This clinical trial seeks to determine the efficacy of evacuation surgery within a 90-day follow up period. The primary outcome measure is the number of patients with recurrent or refractory hematoma (radiographic resolution). Secondary objectives include an assessment of change in National Institutes of Health Stroke Scale score, which are used to gauge neurologic impairments and range from 0 (no stroke symptoms) to 42 (severe impairment), as well as procedure-related complication rate and changes in size of subdural hematomas detected through CT scans."

Answered by AI

Is this research endeavor currently recruiting participants?

"Affirmative. According to clinicaltrials.gov, the trial is still recruiting participants since it was first published on September 19th 2019 and last updated on May 19th 2022. Altogether, 600 patients need to be enlisted from a single site for this medical research."

Answered by AI

How many people have volunteered for this clinical experiment?

"Affirmative. The information displayed on clinicaltrials.gov states that this clinical trial is currently accepting applications and began doing so since September 19th, 2019. It was last updated on May 19th 2022 and seeks 600 participants across a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Middle Meningeal Artery Embolization for Chronic Subdural Hematoma

Osbun 2019. "Middle Meningeal Artery Embolization for Chronic Subdural Hematoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04065113.