RecruitingIntracerebral Hemorrhage

Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial - Part 2

Eligible age

18–80 yrs

Accepts

All genders

Locations

19 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients most likely to benefit, will improve outcomes at 90 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy. FASTEST Part 2 is an extension of the FASTEST Trial where the subgroups include those treated within 2 hours with a positive spot sign on a baseline CT angiogram or patients treated within 90 minutes of stroke onset, with or without a positive spot sign.

Sponsor: Joseph Broderick, MD

You may qualify if…

✓ 1. Patients aged 18-80 years, inclusive
✓ 2. Patients with spontaneous ICH
✓ 3. Able to treat with study medication (rFVIIa/placebo) within 120 minutes of stroke onset or last known well with a positive spot sign on pretreatment CT angiography or treatment within 90 minutes with or without spot sign.
✓ 4. Efforts to obtain informed consent per EFIC guidelines (U.S.) or adherence to country-specific emergency research informed consent regulations (Canada, Germany, Spain, Finland, U.K., Japan, Australia)

You may not qualify 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 or ≥ 60 cc
✕ 4. Blood filling 2/3 or more of one lateral ventricle of the brain, OR, blood filling at least 1/3 of both lateral ventricles.
✕ 5. Pre-existing disability (mRS \> 2)
✕ 6. Symptomatic thrombotic 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)