Department of Research & Evaluation News

Kaiser Permanente Los Angeles Medical Center will conduct a multi-centered, randomized, Phase 3 research study to learn if the experimental drug recombinant Factor VIIa (rFVIIA), 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.

The study entitled “Recombinant Factor VIla (rFVIla) for Acute Hemorrhagic Stroke Administered at Earliest Time,” also referred to as the FASTEST trial, is funded by the National Institutes of Health. The research will be conducted at the Los Angeles Medical 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.

Intracerebral hemorrhage accounts for more than 10% of the estimated 17 million strokes worldwide each year and is the deadliest type of stroke with a mortality rate of more than 40%. Currently, there is no effective treatment for intracerebral hemorrhage.

“Unfortunately, there are not very many therapies for hemorrhagic stroke, and really none that have been scientifically proven to be effective in improving patient outcomes,” said Navdeep Sangha, MD, a neurologist at the Los Angeles Medical Center and lead investigator for the site. “Our hope is that this treatment, which has been used to treat other bleeding disorders, will reduce bleeding from hemorrhagic stroke and improve outcomes for our patients.”

The study will include adults from 18 through 80 years old with spontaneous bleeding in the brain, intracerebral hemorrhage. The study medicine will be given within two hours of stroke onset. Because acute intracerebral hemorrhage 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 family prior to enrollment to allow them to decide about the patient’s participation in the study.

Before the study starts at the Los Angeles Medical Center, 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. The study team from the Los Angeles Medical Center, will be reaching out to community members to gain as much input as possible.

“When someone has a stroke, the first thing they should do is call 911, because we don’t know if they are having a hemorrhagic stroke or an ischemic stroke until they come in and get a CT scan,” said Dr. Sangha. “If they do have a hemorrhagic stroke and come into the emergency room at our medical center, they could potentially receive this treatment as part of our trial. In treating this kind of stroke, every minute matters.”

For more information about the research study, please visit https://redcap.link/FASTEST or contact Dr. Navdeep Sangha and the Clinical Trials Stroke Team: strokeclinicaltrials@kaiserpermanente.onmicrosoft.com.