Status:
UNKNOWN
Endovascular Embolization for Chronic Subdural Hematomas Following Surgical Evacuation
Lead Sponsor:
Augusta University
Conditions:
Chronic SDH and the Efficacy of Embolization
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
This study is designed to evaluate the effectiveness of endovascular embolization of middle meningeal artery following evacuation of subdural hematomas (SDHs) to assess rate of recurrence. The histori...
Detailed Description
The historical standard for treatment of chronic subdural hematomas (SDH) has been through surgical evacuation through burr holes or craniotomies. Many of these patients are elderly patients who are h...
Eligibility Criteria
Inclusion
- Patients 18-90 with chronic SDH
- Patients that require surgical evacuation of SDH following assessment by a neurosurgeon
- Glasgow Coma Scale (GCS) \>6
- Modified Rankin Scale (mRs) \<5
Exclusion
- Patients \< 18 or \>90 years of age
- Pregnancy
- Patients with extensive multisystem trauma requiring multidisciplinary surgical interventions
- Chronic renal insufficiency with creatinine \>1.8
- GCS \<6
- mRs \>4
- Genetic bleeding disorder
- Liver failure
- Coagulopathy
- Patients unable to consent who do not have an LAR available
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04272996
Start Date
March 1 2019
End Date
June 1 2024
Last Update
June 18 2023
Active Locations (1)
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1
Augusta University
Augusta, Georgia, United States, 30912