rFVIIa for Acute hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial

University of Utah Health is conducting a research study of the emergency treatment of patients with bleeding in the brain also called intracerebral hemorrhage. 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. 

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.

University of Utah Hospital has joined a partnership of over 100 other hospitals and mobile stroke units across North America and other countries in the world for this study. We are going to determine if a medicine used to treat and prevent bleeding can also improve a patient’s outcomes after a stroke caused by bleeding in the brain.

Treatment Medicine

The medicine we will be testing is called Recombinant Factor VIIa. Participants in this study will receive either the medicine or a placebo that contains no active medications.

Patients Included

Patients who will be included in this trial are:

  • ages 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:

  1. Placebo: Placebo (no active ingredient) administered intravenously over two minutes.
  2. 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 a 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.

Why FASTEST Is 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:

  • 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.

Opt-Out Instructions

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 three and a half 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:

Kinga Aitken, Research Manager
Phone: 801-581-5523
Email: kinga.aitken@hsc.utah.edu

You can also print your own opt-out card or fill out the opt-out request. You may want to let your family know of your wishes NOT to participate in this study.

Opt Out Options

Resources

We Need to Hear From You

Your input is an important part of our study. Please help us out by filling out this survey. 

Principal Investigator & Researchers

Research Coordinator

Kinga Aitken MPH CCRP
Clinical Research Manager
Phone: 801-581-5523
Email: kinga.aitken@hsc.utah.edu

Opt Out Form

Please fill out this form to opt out of the FASTEST clinical study.