Tampa General Hospital-USF Health Among First in Nation to Enroll Patients in Study of Minimally Invasive Treatment for Subdural Brain Bleeds

Published: Mar 23, 2021
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TAMPA, Fla. (March 23, 2021) – Tampa General Hospital, working with USF Health, is one of the first sites in the country – and the first in Florida – to enroll patients in a new national study testing whether a minimally invasive procedure can safely and effectively treat subacute and chronic subdural hematomas, a common type of brain bleed.

Subacute or chronic subdural hematomas often occur in patients who have brain atrophy, a shrinking or wasting away of brain tissue due to age, trauma, or disease, which results in a slow accumulation of blood over several days to weeks or months.

The standard surgical treatment involves drilling a hole in the skull, or opening a larger portion of the skull, to drain the hematoma. This relieves increasing pressure on the brain that can cause debilitating symptoms such as severe headaches, profound body weakness, vision and speech problems, confusion, and impaired memory. However, recurrent subdural hematomas frequently require repeat surgeries that pose risks – especially for more fragile older patients or others with underlying diseases, who may not be good candidates for open surgery.

The multisite randomized, controlled EMBOLISE clinical study will evaluate an emerging minimally invasive treatment, called middle meningeal arterial (MMA) embolization. The procedure will deliver an embolic liquid (Onyx™ Liquid Embolic System) to block targeted vessels, the underlying source of inflammation and rebleeding promoting the growth of subdural hematomas.

“This study is a significant opportunity to expand our scientific understanding of subdural brain bleeds and marks an important step forward in the discovery of an effective treatment,” said Dr. Charles J. Lockwood, senior vice president of USF Health and dean of the USF Health Morsani College of Medicine. “As the first site in Florida to enroll in the trial, USF Health and Tampa General Hospital are at the forefront of national efforts to pioneer new discoveries that improve outcomes for patients.”

With MMA embolization, a neurointerventional neurologist trained in image-guided techniques inserts a microcatheter through a needlestick in the groin or wrist, threading it up to targeted arteries near the brain. Then, an embolic agent is released to stop the persistent bleeding characteristic of chronic subdural hematomas.

“Middle meningeal arterial embolization represents a fundamentally different approach to managing this complex condition – one that shuts down abnormal blood vessels to break the vicious cycle of continued subdural hematoma growth,” said Maxim Mokin, MD, PhD, principal investigator for EMBOLISE at the Tampa General (TGH) trial site and an associate professor of neurology and neurosurgery at the USF Health Morsani College of Medicine. “If it proves to be as effective as preliminary data indicates, this less invasive procedure may offer the potential for a cure.”

The TGH site will enroll up to 36 adults ages 18 to 90 in the EMBOLISE trial, which is expected to include 600 study participants at medical centers across the country.

MMA embolization is still in the investigational stages for subdural hematomas and does not have FDA approval. This trial is an important step in seeking that approval. Larger, more rigorous studies such as EMBOLISE are needed to validate whether the neurointerventional procedure works.

Earlier case studies and smaller trials suggest that MMA embolization, in conjunction with surgery, often significantly reduces the need for repeat surgeries in some patients with subdural hematomas, Dr. Mokin said. “And in patients closely observed who do not require urgent surgery, the embolization procedure alone demonstrates a dramatic reduction in the size of the hematoma and the alleviation of symptoms, often preventing the more invasive surgical procedure.”

EMBOLISE study participants diagnosed with chronic or subacute hematoma will initially be enrolled into one of two groups: a surgery group or an observational group monitored for changes in hematoma size determined by CT scans and any worsening symptoms. The surgery group will be randomized into two subgroups: study participants who undergo surgery alone (the standard treatment) and those treated with surgery supplemented by investigational MMA embolization. The observational group will also be randomized into one of two subgroups: study participants who continue to be closely observed only (no treatment), and those who receive the investigational MMA embolization.

The primary outcome measure to assess the effectiveness of investigational MMA embolization will be whether the subdural hematoma recurs or progresses within 90 days following either surgery combined with embolization, or embolization alone.

The trial is sponsored by Medtronic, the manufacturer of the Onyx embolic agent used to stop the bleeding.

ABOUT USF HEALTH
USF Health's mission is to envision and implement the future of health. It is the partnership of the USF Health Morsani College of Medicine, the College of Nursing, the College of Public Health, the Taneja College of Pharmacy, the School of Physical Therapy and Rehabilitation Sciences, the Biomedical Sciences Graduate and Postdoctoral Programs, and USF Health's multispecialty physicians group. The University of South Florida is a high-impact global research university dedicated to student success. Over the past 10 years, no other public university in the country has risen faster in U.S. News and World Report's national university rankings than USF. For more information, visit health.usf.edu

ABOUT TAMPA GENERAL HOSPITAL
Tampa General Hospital, a 1007-bed non-profit academic medical center, is one of the largest hospitals in America and delivers world-class care as the region’s only center for Level l trauma and comprehensive burn care. Tampa General Hospital is the highest-ranked hospital in the market in U.S. News & World Report’s 2020-21 Best Hospitals, and one of the top 4 hospitals in Florida, with five specialties ranking among the best programs in the United States. It is one of the nation’s busiest adult solid organ transplant centers and is the primary teaching hospital for the USF Health Morsani College of Medicine. With five medical helicopters, Tampa General Hospital transports critically injured or ill patients from 23 surrounding counties to receive the advanced care they need. Tampa General houses a nationally accredited comprehensive stroke center and its 32-bed Neuroscience Intensive Care Unit is the largest on the West Coast of FloridaIt also is home to the Jennifer Leigh Muma 82-bed Level IV neonatal intensive care unit, and a nationally accredited rehabilitation center. Tampa General Hospital’s footprint includes 17 Tampa General Medical Group Primary Care offices, TGH Family Care Center Kennedy, TGH Brandon Healthplex, TGH Virtual Health and 19 outpatient Radiology Centers. Tampa Bay residents also receive world-class care from the TGH Urgent Care powered by Fast Track network of clinics, and they can even receive home visits in select areas through TGH Urgent Care at Home, powered by Fast Track. As one of the largest hospitals in the country, Tampa General Hospital is first in Florida to partner with GE Healthcare and open a clinical command center that uses artificial intelligences and predictive analytics to improve and better coordinate patient care at a lower cost. For more information, go to www.tgh.org.