What is the FASTEST Trial?
Barrow Neurological Institute is conducting a research study of the emergency treatment of patients with bleeding in the brain, also called intracerebral hemorrhage.
Barrow Neurological Institute 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% of patients die and only 20% 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 2 hours of stroke onset
Participants in this study are put at random, that is by chance, in one of 2 groups:
- Placebo: placebo (no active ingredient) administered intravenously over 2 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 2 minutes
*Both groups will receive standard medical care, including close management of blood pressure and care within the 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 Barrow Neurological Institute, 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.
Enter code LWP9YE97Y to access the survey.
Where can I learn more about the FASTEST Trial?
St. Joseph’s Hospital & Medical Center
Barrow Neurological Institute
2910 North 3rd Avenue
Phoenix, Arizona 85013