Stony Brook University Hospital is conducting a research study of the emergency treatment of patients with bleeding in the brain, also called intracerebral hemorrhage.
Stony Brook has joined a partnership of over 100 other hospitals and mobile stroke units across North America and other countries in the world to study and determine if a medicine used to treat and prevent bleeding can also improve outcomes after a stroke caused by bleeding in the brain.
Bleeding into the brain happens very rapidly and can be deadly. Over 40 percent of patients die and only 20 percent of survivors can care for themselves. There is no scientifically proven treatment for bleeding into the brain.
The medicine is called Recombinant Factor VIIa. Participants in this study will receive either the medicine or a placebo that contains no active medications.
The name of the study is "rFVIIa for Acute hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial." It is sponsored by the National Institutes of Health.
Who will be included?
People who are 18 through 80 years old, with spontaneous bleeding in brain and are able to be treated with study medication within two hours of stroke onset
Study groups:
Participants in this study are put at random, that is by chance, in one of two groups:
- Placebo: placebo (no active ingredient) administered intravenously over two minutes
- Recombinant Factor VIIa (rFVIIa): a protein that our body makes to stop bleeding at site of an injury to a blood vessel, will be administered intravenously over two minutes
*Both groups will receive standard medical care, including close management of blood pressure and care within intensive care unit
Benefits & Risks
Risks: rFVIIa may increase risk of developing life-threatening blood-clots. Blood-clots could cause heart attack, stroke, or serious lung problems. In other studies, this occurred rarely in persons given rFVIIa as compared to placebo
Benefits: Because the purpose of the study is to determine the effectiveness of rFVIIa compared to a placebo, it is not known whether or not you will benefit from being in this study. However, the knowledge gained from this study may help doctors learn more about what treatments are most effective for stroke.
How is FASTEST different than other studies?
Because of the severity of their brain injury, patients eligible for the FASTEST Trial will almost always be unable to say whether or not they wish to participate in the study. A special set of government rules allow studies to include patients with an “exception from informed consent” under these circumstances. This is only allowed in life threatening circumstances, where the best strategy is unknown, when there is a potential benefit to participants, and when it is not possible to get consent from the patients’ families or representatives before the study strategies need to begin. We are asking community members to think about this research and let us know what you think about the FASTEST study.
What if I don’t want to participate in FASTEST?
If you do not wish to be enrolled into the FASTEST research study you must carry an “opt out card” at all times during the study enrollment period (approximately 3 ½ years beginning early 2021. Emergency teams and hospital staff will look for this card, the researchers will know not to enroll you in this study if they locate this card. If you would like a card, please contact the study team at Stony Brook University Hospital, go to the website listed below to print you own card, or fill out the Opt- Out Survey below. You may want to let your family know of your wishes to NOT participate in this study.
Link to Opt-Out card for printing in English: click here
Link to Opt-Out card for printing in Spanish: click here
Where can I learn more about the FASTEST Trial?
Click to learn more about the FASTEST Trial through ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT03496883
Click to learn more about StrokeNet: https://www.nihstrokenet.org
We would like your feedback!
Take the survey in English: https://redcap.research.cchmc.org/surveys/?s=YALHC7W838
Take the survey in Spanish: https://redcap.research.cchmc.org/surveys/?s=Y8HMNK844R
Contact Us!
Jason Mathew, DO
Vascular Neurologist
Stony Brook Cerebrovascular and Comprehensive Stroke Center
Stony Brook Medicine
Stony Brook, NY
Phone: (631) 444-9083
Fax: (631) 546-7191
FASTEST_trial@stonybrookmedicine.edu
Christine Pol, PhD
Clinical Research Associate
Study Coordinator
FASTEST Trial
Stony Brook Medicine
Stony Brook, NY
Phone: (631) 444-9083
Fax: (631) 546-7191
FASTEST_trial@stonybrookmedicine.edu