Henry Ford Hospital is joining researchers at more than 100 other hospitals across the United States and other countries to conduct a stroke research study called FASTEST. This research study may affect you or someone you know. The FASTEST study involves patients who have had bleeding in the brain, also called intracerebral hemorrhage (ICH). ICH occurs when a blood vessel in the brain breaks and blood collects in the brain. Most of this bleeding occurs within a few hours of when symptoms start.
The brain injury from ICH is usually very severe, over 40% of people with ICH die within a month, and only 20% can independently care for themselves after 6 months. There is currently no treatment for ICH that is scientifically proven to improve outcome. The FASTEST research study is being done to determine if a medication called recombinant Factor VIIa (rFVIIa), based on a protein that our body makes to stop bleeding at the site of injury to a blood vessel, can slow bleeding in the brain and improve outcome. rFVIIa is approved for treatment of bleeding in patients who have certain inherited blood clotting problems but is not currently approved for treatment of ICH.
Participants in the FASTEST research study are assigned at random (by chance) into one of 2 groups: rFVIIa or placebo (no active ingredient). In other words, they have an equal chance of getting the study medication (rFVIIa) or placebo in addition to the standard treatment for ICH, which includes close management of blood pressure and care within an intensive care unit. We do not know if rFVIIa is better than placebo for patients with ICH. The results of the FASTEST research study will help doctors discover if rFVIIa improves outcomes in patients with ICH. Because time is an important factor for ICH treatment, participants must start the study within two hours of onset of ICH symptoms. It is possible that you or someone you are acquainted with could be impacted by this research study, and it is essential to gather the community's thoughts on the matter in advance.
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 5 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 or click here to print you own card. You may want to let your family know of your wishes to NOT participate in this study.
Contact Our Study Team
CFP-244
2799 W Grand Blvd
Detroit, MI 48202 Email: EDresearch@hfhs.org
Phone Number: 313-404-9110
Christopher Lewandowski, MD
Clinical Trials Coordinators:
Jo-Ann Rammal
Kathleen Wilson, RN
Study-Related Links
- National Website https://nihstrokenet.org/trials/fastest/home
- ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT03496883
