Recruiting

Endovascular Embolization

Sponsor:

Augusta University

Code:

NCT04272996

Conditions

Chronic SDH and the Efficacy of Embolization

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Craniotomy only

Craniotomy + Endovascular embolization of the middle meningeal vessels

Study Details

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.

Conditions

Chronic SDH and the Efficacy of Embolization

Study ID

NCT04272996

Start date

Mar 1, 2019

Status verified date

Jun, 2023

Completion date

Jun, 2024

Anticipated

Primary completion date

Jun, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: surgery alone

craniotomy for SDH evacuation

active comparator: Surgery plus embolization

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

Interventions

Craniotomy only

evacuation of SDH

Craniotomy + Endovascular embolization of the middle meningeal vessels

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

Primary outcome measure

  • SDH recurrence [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Locations

Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

More Information

Sponsor

Augusta University

Last update posted

Jun 18, 2023

Last verified

Jun, 2023

Keywords

  • subdural hematoma
  • embolization
  • middle meningeal artery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Augusta University on 2023-06-18.