Two Atlanta-area stroke centers announce a randomized controlled trial to evaluate the effectiveness of early surgical intervention using the BrainPath device following spontaneous intracerebral hemorrhage (ICH).
The Emory Stroke Center of Emory University Hospitals and the Marcus Stroke & Neuroscience Center of Grady Memorial Hospital lead the trial, along with the BrainPath device’s maker, NICO Corporation.
The trial will compare the outcomes between early intervention using atraumatic access with BrainPath for fluid evacuation and a medically managed cohort, explains a media release from NICO Corporation.
Up to 10 stroke centers will be included in the trial, which will last approximately 1 year for patient enrollment and 6 months for patient follow-up. Ideal trial candidates are spontaneous supratentorial ICH patients with a good clinical chance of benefiting from the surgical treatment based on well-defined criteria for study enrollment, per the release.
“This randomized trial will allow us to produce prospective data documenting the best course of action for patients we treat with this very deadly form of stroke,” says Dan Barrow, chairman of neurosurgery, Emory University, in the release.
“It underlines our commitment to partnering with other institutions in establishing a standardized minimally invasive approach and contributing to establishing a new standard of care for ICH patients,” he adds.
Studies show that early removal of the blood released from a hemorrhagic stroke could potentially mitigate brain injury. However, the current standard of care calls for medical management of the patient or a “watch and see” protocol that often allows blood to remain in the brain.
The BrainPath device is used to access the hemorrhage site by navigating through the delicate folds and fiber tracks of the brain, displacing brain tissue as it creates a corridor to the hemorrhage site and evacuate the clot, all through an opening the size of a dime, the release explains.
“I have performed over 50 procedures using the BrainPath to access these bleeds,” states Gustavo Pradilla, MD, chief of neurosurgery, Grady Memorial Hospital, in the release. “My early experience is encouraging, and I am hopeful the results of this trial, in addition to the growing body of clinical evidence, will provide a new standard for better outcomes for these patients.”
“It is encouraging that recent ischemic stroke trials have shown clinical success with mechanical technology for the removal of clots. We want to provide the same level of research and validation for treatment protocols for our ICH patients,” says Michael Frankel, chief of neurology, Grady Memorial Hospital, and professor of neurology at Emory, in the release.
“This study could contribute to revolutionizing the standard of care for this high-risk patient population,” he states.
For more information, visit NICO Corporation.
[Source(s): NICO Corporation, PR Newswire]