Endovascular Embolization for Chronic Subdural Hematomas Following Surgical Evacuation

NCT ID: NCT04272996

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2024-06-30

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.

Conditions

Chronic SDH and the Efficacy of Embolization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

surgery alone

craniotomy for SDH evacuation

Group Type: OTHER

Craniotomy only

Intervention Type: PROCEDURE

evacuation of SDH

Surgery plus embolization

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

Group Type: ACTIVE_COMPARATOR

Craniotomy + Endovascular embolization of the middle meningeal vessels

Intervention Type: PROCEDURE

evacuation of SDH + Embolization of middle meningeal vessels using standard techniques.

Interventions

Craniotomy only

evacuation of SDH

Intervention Type: PROCEDURE

Craniotomy + Endovascular embolization of the middle meningeal vessels

evacuation of SDH + Embolization of middle meningeal vessels using standard techniques.

Intervention Type: PROCEDURE

Other Intervention Names

Craniotomy alone

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Augusta University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando L. Vale, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medical College of Georgia-Augusta University

Locations

Augusta University

Augusta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Fernando L Vale, M.D.

Role: CONTACT

fvalediaz@augusta.edu

7067213071

Patty Ray, PhD

Role: CONTACT

paray@augusta.edu

706-721-9680

Facility Contacts

Patty Ray, PhD

Role: primary

paray@augusta.edu

706-721-9680

References

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.

Reference Type: RESULT

PMID: 28935548 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30418606 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29019449 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30798265 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1496700-3

Identifier Type: -

Identifier Source: org_study_id