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Procedure

Endovascular Embolization after Surgical Evacuation for Chronic Subdural Hematoma (endovascular Trial)

N/A
Recruiting
Led By Fernando L. Vale, M.D.
Research Sponsored by Augusta University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Modified Rankin Scale (mRs) <5
Patients that require surgical evacuation of SDH following assessment by a neurosurgeon
Must not have
Liver failure
Patients with extensive multisystem trauma requiring multidisciplinary surgical interventions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare endovascular embolization of middle meningeal artery following surgical evacuation of SDHs to assess rate of recurrence & other complications.

Who is the study for?
This trial is for adults aged 18-90 with chronic subdural hematomas who need surgery, have a Glasgow Coma Scale score over 6, and a Modified Rankin Scale score below 5. It excludes pregnant individuals, those unable to consent without legal representation, severe disability or coma patients, and those with bleeding disorders or major organ failure.
What is being tested?
The study compares standard surgical evacuation of subdural hematomas (craniotomy) against the same surgery followed by endovascular embolization of middle meningeal artery. The goal is to see if adding embolization reduces recurrence rates of the hematoma.
What are the potential side effects?
While specific side effects are not listed here, typical risks may include complications from brain surgery such as infection or bleeding at the site, neurological deficits due to damage during operation or embolization procedure-related issues like vessel injury.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk and take care of myself with little to no help.
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I need surgery to remove a brain bleed as advised by a neurosurgeon.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My liver is not working properly.
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I have multiple injuries needing surgery from different specialists.
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I have a blood clotting disorder.
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I am between 18 and 90 years old.
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I need help with my daily activities due to my health condition.
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My kidney function is low with high creatinine levels.
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I have a genetic condition that affects my blood's ability to clot.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
SDH recurrence

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: surgery aloneExperimental Treatment1 Intervention
craniotomy for SDH evacuation
Group II: Surgery plus embolizationActive Control1 Intervention
surgery for evacuation of SDH followed by embolization of middle meningeal vessel

Find a Location

Who is running the clinical trial?

Augusta UniversityLead Sponsor
215 Previous Clinical Trials
85,630 Total Patients Enrolled
Fernando L. Vale, M.D.Principal InvestigatorMedical College of Georgia-Augusta University

Media Library

Chronic subdural hematoma Research Study Groups: Surgery plus embolization, surgery alone
~9 spots leftby Jan 2026
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