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NCT06181994Recruiting

Middle Meningeal Artery Embolization (MMAE) Outcomes for Chronic Subdural Hematoma (cSDH)

Montefiore Medical Center

Start Date

12/5/2023

Completion Date

12/1/2026

Summary

This multi-center retrospective cohort study aims to investigate the real-world outcomes of chronic subdural hematoma treated with MMAE, including clinical effectiveness, recurrence rates, and safety profile.

Detailed Description

Chronic subdural hematoma (cSDH) is a prevalent neurosurgical condition marked by the accumulation of blood in the subarachnoid space. Primarily affecting elderly individuals, cSDH is associated with significant morbidity and mortality rates. Current standard treatments for cSDH involve surgical evacuation through burr hole craniotomy or twist-drill craniotomy; however, recent research has illuminated the potential significance of the middle meningeal artery (MMA) in cSDH pathogenesis, suggesting an innovative minimally invasive treatment avenue. The investigator team is attempting to determine whether MMA embolization has demonstrated a favorable safety profile with a low incidence of treatment-related complications. While traditional surgical interventions have demonstrated positive outcomes in cSDH management, inherent challenges such as perioperative complications, extended hospital stays, and the risk of recurrence persist. Given the emerging insights into cSDH's underlying mechanisms, targeting the MMA presents an intriguing therapeutic alternative. The MMA, which supplies the dura mater's outer layer, has been implicated in cSDH formation and progression due to its fragility and propensity to rupture. By embolization of the MMA (MMAE), the opportunity arises to potentially mitigate bleeding risk and reduce the likelihood of hematoma reaccumulation. Recent case reports and a significant number of retrospective studies have shown encouraging results with MMA embolization as an adjunct or alternative to conventional surgical methods. Nevertheless, most of the reported studies are case series with limited sample sizes. Moreover, a comprehensive assessment of outcomes, complications, and long-term efficacy necessitates well-structured retrospective studies. The findings of this study hold the potential to better understand the outcomes of MMAE for cSDH. This study aims to provide valuable insights that can guide clinical decision-making, potentially leading to improved patient outcomes and more efficient resource utilization, The following collaborators are also involved in the research: Hamza Adel Salim Email: HASalim@MDAnderson.org Adam A Dmytriw MD MPH MSc Email: adam.dmytriw@gmail.com Rahim Abo Kasem, MD Email: rahim.abokasem@louisville.edu Name: Muhammed Amir Essibayi, MD Email: m.amir.essibayi@gmail.com

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Consecutive adult patients (18 yrs. of age or older) * Endovascular embolization of middle meningeal artery using any embolization material: PVA particles; Onyx, N-butyl cyanoacrylate (nBCA) glue; dimethyl sulfoxide, microcoils, polyvinyl alcohol (PVA) with microcoils Exclusion Criteria: * Endovascular embolization of middle meningeal artery using any other embolization material

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Conditions

Chronic Subdural Hematoma

Locations

Baptist Health South Florida, Inc.

Coral Gables, Florida 33143

United States

Mayo Clinic Florida

Jacksonville, Florida 32224

United States

University of Miami

Miami, Florida 33136

United States

Orlando Regional Medical Center

Orlando, Florida 32806

United States

University of Illinois Chicago

Chicago, Illinois 60607

United States

University of Chicago Medicine

Chicago, Illinois 60637

United States

The University of Iowa

Iowa City, Iowa 52242

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Beth Israel Deaconess Medical Center (BIDMC)/Harvard Medical School

Boston, Massachusetts 02215

United States

Lahey Hospital and Medical Center

Burlington, Massachusetts 01805

United States

Allina Health

Minneapolis, Minnesota 55404

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Montefiore Medical Center

The Bronx, New York 10467

United States

Geisinger Health

Danville, Pennsylvania 17822

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19144

United States

UTHealth Houston

Houston, Texas 77030

United States

HCA Houston Healthcare Kingwood

Kingwood, Texas 77339

United States

West Virginia University

Morgantown, West Virginia 26506

United States

Austin Health

Heidelberg, Victoria 3084

Australia

Unity Health Toronto

Toronto, Ontario M5C 2T2

Canada

University of Toronto

Toronto, Ontario M5S 1A1

Canada

Toronto Western Hospital

Toronto, Ontario M5T 2S8

Canada