(Philadelphia, PA) – Temple University Hospital (TUH) 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 (ICH).
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 (NIH). The research will be conducted at Temple University Hospital. 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% 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 ICH.
“We are pleased that Temple University Hospital will be one of the sites participating in the FASTEST clinical trial and researching the drug rFVlla given the lack of treatments available for this deadly condition,” said Nina Gentile, MD, Professor and Vice Chair for Research in the Department of Emergency Medicine at the Lewis Katz School of Medicine at Temple University and Principal Investigator for the trial at TUH.
The study will include adults from 18 through 80 years old with 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 using delayed consent if unconscious and 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 Temple University Hospital, 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. Temple University Hospital will be reaching out to community members to gain as much input as possible.
For more information about the research study, visit https://nihstrokenet.org/fastest/community-resources or https://redcap.link/FASTEST or contact Dr. Gentile and the study team at EDResearch@tuhs.temple.edu.
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About Temple Health
Temple University Health System (Temple Health) is a $2.4 billion academic health system dedicated to providing access to quality patient care and supporting excellence in medical education and research. Temple Health includes Temple University Hospital (TUH)-Main Campus; TUH-Episcopal Campus; TUH-Jeanes Campus; TUH-Northeastern Campus; Temple University Hospital – Fox Chase Cancer Center Outpatient Department; TUH-Northeastern Endoscopy Center; The Hospital of Fox Chase Cancer Center, together with The Institute for Cancer Research, an NCI-designated comprehensive cancer center; Fox Chase Cancer Center Medical Group, Inc., The Hospital of Fox Chase Cancer Center’s physician practice plan; Temple Transport Team, a ground and air-ambulance company; Temple Physicians, Inc., a network of community-based specialty and primary-care physician practices; and Temple Faculty Practice Plan, Inc., Temple Health’s physician practice plan. Temple Health is affiliated with the Lewis Katz School of Medicine at Temple University.
Temple Health refers to the health, education and research activities carried out by the affiliates of Temple Health and by the Katz School of Medicine. Temple Health neither provides nor controls the provision of health care. All health care is provided by its member organizations or independent health care providers affiliated with Temple Health member organizations. Each Temple Health member organization is owned and operated pursuant to its governing documents.
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