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Endovascular Embolization for Chronic Subdural Hematomas Following Surgical Evacuation

Endovascular Embolization for Chronic Subdural Hematomas Following Surgical Evacuation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04272996
Acronym
endovascular
Enrollment
60
Registered
2020-02-17
Start date
2019-03-01
Completion date
2024-06-30
Last updated
2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic SDH and the Efficacy of Embolization

Keywords

subdural hematoma, embolization, middle meningeal artery

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.

Interventions

PROCEDURECraniotomy only

evacuation of SDH

PROCEDURECraniotomy + Endovascular embolization of the middle meningeal vessels

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

Sponsors

Augusta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
SDH recurrence3 monthsRadiographic assessment of SDH recurrence

Countries

United States

Contacts

Primary ContactFernando L Vale, M.D.
fvalediaz@augusta.edu7067213071
Backup ContactPatty Ray, PhD
paray@augusta.edu706-721-9680

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026