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Endovascular Embolization for Chronic Subdural Hematomas Following Surgical Evacuation (endovascular)

Primary Purpose

Chronic SDH and the Efficacy of Embolization

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Craniotomy only
Craniotomy + Endovascular embolization of the middle meningeal vessels
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic SDH and the Efficacy of Embolization focused on measuring subdural hematoma, embolization, middle meningeal artery

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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

Sites / Locations

  • Augusta UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

surgery alone

Surgery plus embolization

Arm Description

craniotomy for SDH evacuation

surgery for evacuation of SDH followed by embolization of middle meningeal vessel

Outcomes

Primary Outcome Measures

SDH recurrence
Radiographic assessment of SDH recurrence

Secondary Outcome Measures

Full Information

First Posted
February 11, 2020
Last Updated
June 14, 2023
Sponsor
Augusta University
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1. Study Identification

Unique Protocol Identification Number
NCT04272996
Brief Title
Endovascular Embolization for Chronic Subdural Hematomas Following Surgical Evacuation
Acronym
endovascular
Official Title
Endovascular Embolization for Chronic Subdural Hematomas Following Surgical Evacuation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Augusta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 historical standard for treatment of subdural hematomas has been surgical evacuation through burr holes or craniotomies. Many of these patients are elderly patients who are high risk surgical candidates. A major concern is SDH recurrence. Recurrences require frequent imaging, and will lead to increased length of hospital stay, increased morbidity,and re-operations. There are increasing number of reports that suggest that a less invasive approach such as endovascular embolization of the middle meningeal artery using standard endovascular materials and techniques may reduce the risk of recurrence. The reported outcomes in the current literature have been very positive when endovascular embolization has been used without surgery or as an adjuvant to surgery. However, there have been no studies directly comparing endovascular embolization following surgical evacuation to assess if this technique can actually reduce the complications of SDHs listed above. The investigators propose to study this treatment process by randomly assigning patients who have undergone surgical evacuation of SDHs into a control and treatment group. The control group will receive standard surgical evacuation of the hematoma. The study group will receive surgical evacuation followed by endovascular embolization.
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 high risk surgical candidates. Unfortunately given the pathophysiology of SDHs there is a high rate of recurrence ranging 5-30% in the literature necessitation frequent imaging, increased length of hospital stay, increased morbidity, and increased rate of reoperations. A more novel and less invasive approach has been used to treat SDHs in this patient population. There are increasing reports of endovascular embolization of the middle meningeal artery using a less invasive endovascular approach for SDHs. The reported outcomes in literature have been very positive when endovascular embolization has been used without surgery or as an adjuvant to surgery. These reports include case series and retrospective reviews. There have been no studies directly comparing endovascular embolization following surgical evacuation to assess if this technique can actually benefit patients with chronic SDHs. The investigators propose to study this treatment process by randomly assigning patients who have undergone surgical evacuation of SDHs through burr holes into a control and treatment group. The control group (surgery) would only receive surgical evacuation of the hematoma using current standard of care. The treatment group (surgery plus) would receive surgical evacuation followed by endovascular embolization of the middle meningeal vessels using current standard of care. We will directly compare these two treatment modalities to obtain class I evidence on the efficacy of embolization for treatment of chronic subdural hematomas.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic SDH and the Efficacy of Embolization
Keywords
subdural hematoma, embolization, middle meningeal artery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The control group (surgery) would only receive surgical evacuation of a hematoma using current standard of care. The treatment group (surgery plus) would receive surgical evacuation followed by endovascular embolization of the middle meningeal vessels using current standard of care. We will directly compare these two treatment modalities to obtain class I evidence on the efficacy of embolization for treatment of chronic subdural hematomas.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
surgery alone
Arm Type
Other
Arm Description
craniotomy for SDH evacuation
Arm Title
Surgery plus embolization
Arm Type
Active Comparator
Arm Description
surgery for evacuation of SDH followed by embolization of middle meningeal vessel
Intervention Type
Procedure
Intervention Name(s)
Craniotomy only
Other Intervention Name(s)
Craniotomy alone
Intervention Description
evacuation of SDH
Intervention Type
Procedure
Intervention Name(s)
Craniotomy + Endovascular embolization of the middle meningeal vessels
Intervention Description
evacuation of SDH + Embolization of middle meningeal vessels using standard techniques.
Primary Outcome Measure Information:
Title
SDH recurrence
Description
Radiographic assessment of SDH recurrence
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fernando L Vale, M.D.
Phone
7067213071
Email
fvalediaz@augusta.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Patty Ray, PhD
Phone
706-721-9680
Email
paray@augusta.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando L. Vale, M.D.
Organizational Affiliation
Medical College of Georgia-Augusta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patty Ray, PhD
Phone
706-721-9680
Email
paray@augusta.edu
First Name & Middle Initial & Last Name & Degree
Luca Debs, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28935548
Citation
Sahyouni R, Goshtasbi K, Mahmoodi A, Tran DK, Chen JW. Chronic Subdural Hematoma: A Historical and Clinical Perspective. World Neurosurg. 2017 Dec;108:948-953. doi: 10.1016/j.wneu.2017.09.064. Epub 2017 Sep 19.
Results Reference
result
PubMed Identifier
30418606
Citation
Link TW, Boddu S, Paine SM, Kamel H, Knopman J. Middle Meningeal Artery Embolization for Chronic Subdural Hematoma: A Series of 60 Cases. Neurosurgery. 2019 Dec 1;85(6):801-807. doi: 10.1093/neuros/nyy521.
Results Reference
result
PubMed Identifier
29019449
Citation
Ban SP, Hwang G, Byoun HS, Kim T, Lee SU, Bang JS, Han JH, Kim CY, Kwon OK, Oh CW. Middle Meningeal Artery Embolization for Chronic Subdural Hematoma. Radiology. 2018 Mar;286(3):992-999. doi: 10.1148/radiol.2017170053. Epub 2017 Oct 10.
Results Reference
result
PubMed Identifier
30798265
Citation
Fiorella D, Arthur AS. Middle meningeal artery embolization for the management of chronic subdural hematoma. J Neurointerv Surg. 2019 Sep;11(9):912-915. doi: 10.1136/neurintsurg-2019-014730. Epub 2019 Feb 23.
Results Reference
result

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Endovascular Embolization for Chronic Subdural Hematomas Following Surgical Evacuation

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