jRCTs051200076RecruitingNot Applicable
The investigator-initiated international clinical trial on efficacy and safety of recombinant factor VIIa for hyperacute intracerebral hemorrhage (FASTEST)
Not provided0 sites446 target enrollmentStarted: July 20, 2022Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 446
- Primary Endpoint
- ordinal modified Rankin Scale (mRS) at 180 days
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Double Blind
Eligibility Criteria
- Ages
- 20age old over to 80age old under (—)
- Sex
- All
Inclusion Criteria
- •Patients aged 20 to 80 years with spontaneous intracerebral hemorrhage who can be treated within 120 minutes of stroke onset or last-known-well
- •Part2: Patients aged 20 to 80 years with spontaneous intracerebral hemorrhage who can be treated within 120 minutes of stroke onset or last-known-well with a positive spot sign on CTA.
Exclusion Criteria
- •Score of 3 to 7 on the Glasgow Coma Scale
- •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.)
- •ICH volume < 2 cc and => 60 cc
- •Blood filling 2/3 or more of one lateral ventricle of the brain, OR, blood filling at least 1/3 of both lateral ventricles
- •Pre-existing disability (mRS > 2)
- •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)
- •Clinical or EKG evidence of ST elevation consistent with acute myocardial ischemia
- •Brainstem location of hemorrhage (patients with cerebellar hemorrhage may be enrolled)
- •Refusal to participate in study by patient, legal representative, or family member
- •Known or suspected thrombocytopenia (unless current platelet count documented above 50,000/micro L)
- •Unfractionated heparin use with abnormal PTT
- •Pro-coagulant drugs within 24 hours prior to patient enrollment into the FASTEST trial (example, tranexamic acid or aminocaproic acid)
- •Low-molecular weight heparin use within the previous 24 hours
- •Recent (within 90 days) carotid endarterectomy or coronary or cerebrovascular angioplasty or stenting
- •Advanced or terminal illness or any other condition the investigator feels would pose a significant hazard to the patient if rFVIIa were administered
- •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
- •Planned withdrawal of care or comfort care measures
- •Patient known or suspected of not being able to comply with trial protocol (e.g., due to alcoholism, drug dependency, or psychological disorder)
- •Known or suspected allergy to trial medication(s), excipients, or related products
- •Contraindications to study medication
- •Previous participation in this trial (previously randomized)
- •Females of childbearing potential who are known to be pregnant or within 12 weeks post-partum and/or lactating at time of enrollment
Outcomes
Primary Outcomes
ordinal modified Rankin Scale (mRS) at 180 days
Time Frame: 180 days
0-2, 3, and 4-6
distribution of the ordinal mRS at 90 days
Time Frame: 90 days
0-2, 3, and 4-6
life-threatening thromboembolic complications
Time Frame: during the first four days after completion of study drug
acute myocardial infarction, acute cerebral infarction, and acute pulmonary embolism
Secondary Outcomes
- ordinal mRS (all seven steps)(90 days and 180 days)
- utility-weighted Rankin Score(90 days and 180 days)
- mRS of 0-2(90 days and 180 days)
- EQ-5D(90 days and 180 days)
- change in the volume of intracerebral hemorrhage(baseline CT and 24 hour CT)
- change in the volume of (intracerebral hemorrhage + intraventricular hemorrhage)(baseline CT and 24 hour CT)
- mortality(180 days)
- mRS of 5-6(180 days)
- modified Rankin Scale (mRS)(180 days)
Investigators
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