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FASTEST

An emergency care research study of bleeding in the brain.

The UMass Medical School is conducting a research study to study bleeding in the brain, also called intracerebral hemorrhage (ICH). Most of this bleeding occurs within a few hours of onset of symptoms. The brain injury from ICH is usually very severe, and there is currently no treatment for ICH that is proven to improve outcome. The FASTEST research study is being done to determine if a protein (rFVIIa) 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. Participants in the FASTEST research study are placed at random, that is by chance, into one of 2 groups. They have an equal chance of getting rFVIIa or placebo (no active ingredient). 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 contact our study staff below.

Primary Investigator: Dr. Adalia Jun-O’Connell, MD, adalia.jun@umassmemorial.org, 508-334-2527

Study Coordinator: Ms. Lauren Vilchinsky, lauren.vilchinsky@umassmed.edu, 508-856-4667

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Site Primary Investigator (UMASS): Adalia Jun-O’Connell, MD

Design: Phase III, randomized, double-blind controlled trial of rFVIIa plus best standard therapy vs. placebo and best standard therapy alone

Funding: National Institute of Health/National Institute for Neurological Diseases and Stroke (NIH/NINDS) and StrokeNet

Objectives:

Primary Objective: To test the hypothesis that treatment with rFVIIa within two hours of onset in appropriately selected patients with spontaneous ICH improves outcome as measured by the ordinal distribtution of the modfied Rankin Scale (mRS) at 180 days, as compared to placebo.

Secondary Objective: To test the hypothesis that treatment with rFVIIa within two hours of onset in appropriatley selected patients with spontaneous ICH decreases bleeding between baseline and 24-hour head imaging, as compared to placebo

Outcome measures: The primary outcome measure is the following distribution of the ordinal mRS at 180 days: 0-2, 3, and 4-6

Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT03496883term=fastest&draw=2&rank=1