Wednesday, May 12, 2021
Neuroscientists at Northwell Health’s Institute for Neurology and Neurosurgery and The Feinstein Institutes for Medical Research will conduct a multi-centered, randomized, Phase 3 research study to learn if the experimental drug recombinant Factor Vlla (rFVllA), a protein that our body makes, can be used to decrease bleeding in the brain of patients who suffer sudden bleeding in the brain, also called intracerebral hemorrhage (ICH).
The study, entitled “Recombinant Factor Vlla (rFVlla) for Acute Hemorrhagic Stroke Administered at Earliest Time,” also referred to as the FASTEST trial, is funded by the National Institutes of Health (NIH). The research will be conducted at North Shore University Hospital (NSUH), a comprehensive stroke center. Participants in the clinical trial will receive either the experimental drug rFVlla or a placebo (no active ingredient), and the best standard medical care.
ICH accounts for more than 10 percent of the estimated 17 million strokes worldwide each year and is the deadliest type of stroke with a mortality rate of more than 40 percent. Currently, there is no effective treatment for ICH.
“Intracerebral hemorrhage occurs when a diseased blood vessel within the brain bursts, allowing blood to leak inside the brain causing an increase in pressure,” said Richard Temes, MD, Northwell Health’s director, Center for Neurocritical Care and principal investigator of the FASTEST study at NSUH. “The sudden increase in pressure can cause damage to brain cells. Our hope is that rFVlla, if administered within two hours of onset in appropriately selected patients with spontaneous ICH, results in decreased bleeding as compared to placebo. The findings of the FASTEST study will help us better determine if rFVlla improves outcome for stroke patients.”
The study will include adults from 18 through 80 years old with spontaneous bleeding in the brain, ICH. The study medicine will be given within two hours of stroke onset. Because acute ICH is a life-threatening condition requiring immediate treatment, some patients will be enrolled without consent if unconscious or a family member or other representative is not readily available. Every attempt will be made to locate the family prior to enrollment to allow them to decide about the patient’s participation in the study.
Before the study starts at NSUH, one of the requirements to be a participating site is to engage in community outreach efforts to provide information, answer questions and get community members’ input about this important clinical research. NSUH will be reaching out to community members to gain as much input as possible.
“The FASTEST trial is another example of our commitment to advance acute hemorrhagic stroke treatments into clinical practice and improve outcomes for stroke patients,” said Kevin J. Tracey, MD, president and CEO of the Feinstein Institutes.
