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

Q: What criteria must one meet to qualify for the experiment?

This medical trial requires participants to have chronic subdural hematoma and be within the ages of 18 and 90. 60 patients are being sought for this clinical study.

Q: Is this clinical trial open to those under 45 years old?

This clinical trial stipulates that <a href="https://www.withpower.com/clinical-trials/all">all</a> participants must be between 18 to 90 years old. Additionally, there are 4 studies open for the younger demographic and 64 for those of a more advanced age.

Q: How many participants are being accepted to partake in this experiment?

Affirmative. Examining the information on clinicaltrials.gov, it is evident that this research study launched in March of 2019 and was refreshed as recently as June 14th 2023. Currently, 60 volunteers are needed to take part at 1 medical centre.

Q: Is enrollment open for this research protocol at the present time?

According to the information on clinicaltrials.gov, this medical research is in search of participants and has been updated as recently as June 14th 2023. The trial was first posted March 1st 2019.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

endovascular Trial 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.Check my eligibility

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.See study design

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.

endovascular Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I can walk and take care of myself with little to no help.

Select...

I need surgery to remove a brain bleed as advised by a neurosurgeon.

endovascular Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

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

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

Primary outcome measures

SDH recurrence

endovascular 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Augusta UniversityLead Sponsor

211 Previous Clinical Trials

85,008 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

Frequently Asked Questions

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

What criteria must one meet to qualify for the experiment?

"This medical trial requires participants to have chronic subdural hematoma and be within the ages of 18 and 90. 60 patients are being sought for this clinical study."

Answered by AI

Is this clinical trial open to those under 45 years old?

"This clinical trial stipulates that all participants must be between 18 to 90 years old. Additionally, there are 4 studies open for the younger demographic and 64 for those of a more advanced age."

Answered by AI

How many participants are being accepted to partake in this experiment?

"Affirmative. Examining the information on clinicaltrials.gov, it is evident that this research study launched in March of 2019 and was refreshed as recently as June 14th 2023. Currently, 60 volunteers are needed to take part at 1 medical centre."

Answered by AI

Is enrollment open for this research protocol at the present time?

"According to the information on clinicaltrials.gov, this medical research is in search of participants and has been updated as recently as June 14th 2023. The trial was first posted March 1st 2019."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Endovascular Embolization for Chronic Subdural Hematomas Following Surgical Evacuation

2019. "Endovascular Embolization for Chronic Subdural Hematomas Following Surgical Evacuation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04272996.