Two Advocate Aurora Health hospitals have joined a clinical trial studying a potential treatment for people with a subdural hematoma.
“A subdural hematoma is bleeding that takes place in the layers of tissue between the brain and the skull,” said neurosurgeon Glen Pollock, MD, the study’s principal investigator for Aurora St. Luke’s Medical Center in Milwaukee. “The bleeding comes from a torn blood vessel that is often, but not always, the result of a head injury.”
Advocate Aurora Research Institute has opened the study at Advocate Lutheran General Hospital in Park Ridge, Illinois, and Aurora St. Luke’s, which is the first site in Wisconsin to join the clinical trial.
Subdural hematomas may be subacute or chronic. The subacute type is generally the most dangerous, often occurring immediately after a head injury. If not treated quickly, it can lead to paralysis or death. Chronic subdural hematomas are more common in older adults and can occur from even minor head injuries. Because the bleeding happens more slowly, the development of symptoms can be more subtle and harder to notice.
The clinical trial evaluates the safety and effectiveness of a procedure called embolization using the investigational study device – the Medtronic Onyx™ Liquid Embolization System (LES) – for people with a symptomatic subacute or chronic subdural hematoma.
“Embolization is a minimally invasive procedure that involves guiding a catheter through the body’s blood vessels and deploying an embolic agent to block a blood vessel,” said neurosurgeon Joshua Billingsley, MD, study principal investigator for Advocate Lutheran General. “In the case of a subdural hematoma, embolization of a specific artery can stop the internal bleeding and result in complete resolution of the hematoma.”
The standard treatment for a subdural hematoma is to surgically access the space between the skull and the brain and drain the excess blood. However, this does not stop the flow of blood, which is the underlying cause of the hematoma. Embolization addresses this by closing off the leaking blood vessel.
Researchers will randomize clinical trial participants to receive either the standard treatment for a subdural hematoma or standard treatment plus embolization using the study device.
Participants who are selected to receive the investigational treatment will have the study device injected via a catheter into the middle meningeal artery, the blood vessel in the brain that is thought to be leaking blood. The study device is actually a liquid material that hardens when it comes in contact with blood. Researchers anticipate this will stop the flow of blood that is causing the subdural hematoma.
Onyx™ LES is approved by the U.S. Food and Drug Administration for use in patients who have brain malformations, but not for treatment of patients with symptomatic subacute or chronic subdural hematomas, which is why researchers are studying its use in a clinical trial.
“Patients with subdural hematomas, particularly chronic subdural hematomas, are often older and face an increased risk of complications during and after invasive surgery,” said Katie Wozniak, director of neuroscience clinical trials research. “Advocate Aurora Research Institute is proud to offer clinical trials such as this that search for more effective and less invasive treatments.”
The study, “Embolization of the middle meningeal artery with ONYX™ Liquid Embolic System for subacute and chronic subdural hematoma (EMBOLISE),” is sponsored by Medtronic, manufacturer of the study device.
To learn more about Advocate Aurora’s research, visit aurora.org/research.