Chronic Subdural Hematoma Treatment with Embolization versus Surgery Study (CHESS)
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What exactly is a Chronic Subdural Hematoma (CSDH)?
Chronic subdural hematoma (CSDH) is a common neurological disease with a significant health burden. CSDH is a debilitating pathological entity that affects 1-5.3 per 100,000 annually and is projected to affect 60,000 Americans over the age of 65 annually by 2030. Hospitalization and treatment cost per patient in the United States ranges roughly between $20,000 to $35,000. Population based analysis suggest that the frequency of CSDH will likely double due to increasing population age and use of anticoagulation by 2030. It is likely that the cost of care will increase significantly as well. While the cost of care remains high, the outcomes of CSDH are poor in up to 20% of patients treated with conventional surgery, resulting in significant disability.
Patients with CSDH present with a variety of symptoms of different severity. They can range from headaches, seizure, cognitive decline, numbness, aphasia, weakness, and altered mental status.
For decompensating patients presenting with profound neurological symptoms, conventional surgery is the standard of care. Surgical drainage improves neurologic status and prevents further decline in patients with large CSDHs10. Conventional surgery is surgical drainage through burr holes or craniotomy.
Middle meningeal artery embolization (MMAE) is a minimally invasive emerging therapy for patients with CSDH. Preliminary experience7,8,9 suggests that compared with conventional surgery, MMAE, either as a standalone treatment or as an adjunct to surgery, has been associated with a decrease in the hematoma size and a reduced need for rescue operation.
Thus far there is no data from randomized clinical trials comparing the safety and efficacy of MMAE to conventional surgery for patients with moderately symptomatic CSDH. This gap in knowledge creates uncertainty in the management of moderately symptomatic CSDH patients.
CHESS Study Design
Therefore, the CHESS (NCT #06347796) study design is a prospective, multi-center, randomized, controlled, open-label clinical trial. Patients with moderately symptomatic CSDH are randomized in a 1:1 ratio to MMAE or conventional surgery.
The goal is to randomize 394 adults age 40-90 years inclusively with moderately symptomatic de novo or recurrent subdural hematoma (SDH). Once randomization occurs, subjects assigned to MMAE will undergo particle embolization with Embosphere Microspheres or CONTOUR Embolization Particles per protocol while subjects assigned to surgery will undergo burr hole drainage or craniotomy based on the judgement of the treating physician. Subjects will be considered to be enrolled in this study when they are randomized.
Participants will undergo repeated assessments at regular intervals from the day of enrollment until the end of a 180 day follow up period.
The primary endpoint is to determine the proportion of subjects centrally deemed (per clinical review committee) to need rescue surgery or die within 180 days of randomization.
