Recombinant factor VIIa for hemorrhagic stroke treatment at earliest possible time (FASTEST): Protocol for a phase III, double-blind, randomized, placebo-controlled trial. Issue 7 (August 2022)

• Record Type: Journal Article
• Authors: Naidech, Andrew M; Grotta, James; Elm, Jordan; Janis, Scott; Dowlatshahi, Dar; Toyoda, Kazunori; Steiner, Thorsten; Mayer, Stephan A; Khanolkar, Pooja; Denlinger, Julie; Audebert, Heinrich J; Molina, Carlos; Khatri, Pooja; Sprigg, Nikola; Vagal, Achala; Broderick, Joseph P
• Is Part Of: International journal of stroke. Volume 17:Issue 7(2022)
• Page Start: 806
• Page End: 809
• Publication Date: 2022-08
• Subjects: Cerebral hemorrhage -- hemorrhagic stroke -- factor VII -- hemostasis -- clinical trial -- randomized controlled trial; 616.8005
• DOI: 10.1177/17474930211042700
• Languages: English
• ISSNs: 1747-4930

Abstract

Introduction: Intracerebral hemorrhage is the deadliest form of stroke. Hematoma expansion, growth of the hematoma between the baseline computed tomography scan and a follow-up computed tomography scan at 24 ± 6 h, predicts long-term disability or death. Recombinant factor VIIa (rFVIIa) has reduced hematoma expansion in previous clinical trials with a variable effect on clinical outcomes, with the greatest impact on hematoma expansion and potential benefit when administered within 2 h of symptom onset. Methods: Factor VIIa for Hemorrhagic Stroke Treatment at Earliest Possible Time (FASTEST, NCT03496883) is a randomized controlled trial that will enroll 860 patients at ∼100 emergency departments and mobile stroke units in five countries. Patients are eligible for enrollment if they have acute intracerebral hemorrhage within 2 h of symptom onset confirmed by computed tomography, a hematoma volume of 2 to 60 mL, no or small volumes of intraventricular hemorrhage, do not take anticoagulant medications or concurrent heparin/heparinoids (antiplatelet medications are permissible), and are not deeply comatose. Enrolled patients will receive rFVIIa 80 µg/kg or placebo intravenously over 2 min. The primary outcome measure is the distribution of the ordinal modified Rankin Scale at 180 days. FASTEST is monitored by a Data Safety Monitoring Board. Safety endpoints include thrombotic events (e.g. myocardial infarction). Human subjects research is monitored by an external Institutional Review Board in participating countries. Discussion: In the US, FASTEST will be first NIH StrokeNet Trial with an Exception from Informed Consent which allows enrollment of non-communicative patients without an immediately identifiable proxy.