FASTEST Trial - Version 6.0 - 06-May-2020
Research type
Research Study
Full title
Recombinant Factor VIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial
IRAS ID
287169
Contact name
Nikola Sprigg
Contact email
Sponsor organisation
University of Cincinnati
Eudract number
2019-003722-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 11 months, 16 days
Research summary
Bleeding into the brain (acute haemorrhagic stroke) can cause permanent brain damage and result in long term disability. There is also a chance that the bleeding can increase, which may cause worse disability or be life threatening. This happens in approximately 20-30% of haemorrhagic stroke patients.
At present, there is no available treatment that is effective at reducing the bleeding in the brain and improving the recovery.
The purpose of the FASTEST trial is to evaluate if a medicine used to treat and prevent bleeding improves outcomes after acute haemorrhagic stroke. The medicine is called Recombinant Factor VIIa. rFVIIa is identical to a protein made in the body to help form blood clots. rFVIIa has been used for many years to treat and prevent bleeding episodes in patients with coagulation disorders, but is not yet licensed for use in haemorrhagic stroke.
In this international, multicentre, randomized, double-blinded clinical trial participants meeting the entry criteria will receive a single intravenous bolus of either rFVIIa or placebo (contains no active medications) in addition to their standard of care treatment within two hours of onset of acute haemorrhagic stroke. 30 days, 90 days and 180 days after stroke onset the study participants will be followed up either in-person or remotely (by video or telephone) for assessment of their health and functional outcome.
860 subjects are planned to be included in the study over 3 1/2 years at approximately 115 hospital sites and 15 mobile stroke units in Canada, Germany, Japan, Spain, the UK and the US.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
20/SC/0377
Date of REC Opinion
17 Dec 2020
REC opinion
Further Information Favourable Opinion