What is the FASTEST trial?
FASTEST is an NIH-sponsored research study on the emergency treatment of patients with bleeding in the brain, also called intracerebral hemorrhage. The University of Chicago Medical Center 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 are able to care for themselves. There is no scientifically proven treatment for bleeding into the brain. The medicine used in this study 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.
Who is eligible for this study?
Patients who are 18-80 years old,
with spontaneous bleeding in the brain,
and are able to be treated with the study medication within 2 hours of stroke onset will be eligible for the FASTEST Trial.
Participants in this study are put at random, that is by chance, in one of 2 groups:
|Placebo:||Recombinant Factor VIIa (rFVIIa):|
|A placebo (no active ingredient) will be administered intravenously over 2 minutes.||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 intensive care unit
Risks & benefits
|What are the risks?||What are the benefits?|
|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.||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 from other studies?
What if I don't wish 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, and 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 (773-702-0235), visit the website below, or alternatively fill out the Opt-Out Survey. You may want to let your family know of your wishes to NOT participate in this study.
|Printable Card||Opt-Out Survey|
Where can I learn more about the FASTEST Trial?
To learn more about the FASTEST Trial through ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT03496883
To learn more about StrokeNet: https://www.nihstrokenet.org/