Chronic SDH and the Efficacy of Embolization Clinical Trial
— endovascularOfficial title:
Endovascular Embolization for Chronic Subdural Hematomas Following Surgical Evacuation
| NCT number | NCT04272996 |
| Other study ID # | 1496700-3 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 1, 2019 |
| Est. completion date | June 2024 |
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.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | June 2024 |
| Est. primary completion date | June 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 90 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Augusta University | Augusta | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| Augusta University |
United States,
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. — View 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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | SDH recurrence | Radiographic assessment of SDH recurrence | 3 months |