Fastest Trial

This emergency care research study of bleeding in the brain will be performed in this area.

The Medical University of South Carolina 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.  Some patients will be enrolled without consent if a family member or representative is not rapidly available. Before the research study starts, we will consult with the community.

We welcome your feedback and questions.  For more information or to decline participation in this research study, please visit https://www.nihstrokenet.org/fastest/community-resources or contact our research study staff at (843) 792-8606.

Primary Investigator: Dr. Christine Holmstedt

Study Coordinator: Vicki Streets

Study-Related Links

We need your feedback! Please click here to complete a short survey about FASTEST: RedCap Feedback Survey

Opt Out Card

Participating US Sites