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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Diana
Salein
d.salein@clinical-research-services.de
Prof
Philip
Bath
philip.bath@nottingham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Cerebrovascular diseases
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;
You can take part if:
You may not be able to take part if:
1) Score of 3 to 7 on the Glasgow Coma Scale 2) Secondary ICH related to known causes (e.g., trauma, aneurysm, arteriovenous malformation (AVM), oral anticoagulant use (vitamin K antagonists or novel oral anticoagulants) within the past 7 days, coagulopathy, etc.) 3) ICH volume < 2 cc and > = 60 cc 4) IVH (intraventricular hemorrhage) score > 7 5) Pre-existing disability (mRS > 2) 6) Symptomatic thrombo-embolic or vaso-occlusive disease in past 90 days (e.g., cerebral infarction, myocardial infarction, pulmonary embolus, deep vein thrombosis, or unstable angina) 7) Clinical or EKG evidence of ST elevation consistent with acute myocardial ischemia 8) Brainstem location of hemorrhage (patients with cerebellar hemorrhage may be enrolled) 9) Refusal to participate in study by patient, legal representative, or family member 10) Known or suspected thrombocytopenia (unless current platelet count documented above 50,000/μL) 11) Unfractionated heparin use with abnormal PTT 12) Low-molecular weight heparin use within the previous 24 hours 13) Recent (within 90 days) carotid endarterectomy or coronary or cerebrovascular angioplasty or stenting 14) Advanced or terminal illness or any other condition the investigator feels would pose a significant hazard to the patient if rFVIIa were administered 15) Recent (within 30 days) participation in any investigational drug or device trial or earlier participation in any investigational drug or device trial for which the duration of effect is expected to persist until to the time of FASTEST enrollment 16) Planned withdrawal of care or comfort care measures 17) Patient known or suspected of not being able to comply with trial protocol (e.g., due to alcoholism,drug dependency, or psychological disorder) 18) Known or suspected allergy to trial medication(s), excipients, or related products 19) Contraindications to study medication 20) Previous participation in this trial (previously randomized) 21) Females of childbearing potential who are known to be pregnant or within 12 weeks post-partum and/or lactating at time of enrollment
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Diana
Salein
d.salein@clinical-research-services.de
Prof
Philip
Bath
philip.bath@nottingham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Cincinnati (Ohio, USA) and funded by National Institutes of Health (NIH), United States .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 47138
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