EUCTR2019-003722-25-GB进行中（未招募）1 期
Recombinant Factor VIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial - FASTEST Trial - Version 6.0 - 06-May-2020
niversity of Cincinnati0 个研究点目标入组 860 人开始时间: 2020年9月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 860
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Patients aged 18-80 years, inclusive
- •2) Patients with spontaneous ICH (intracerebral hemorrhage)
- •3) Able to treat with study medication (rFVIIa/placebo) within 120 minutes of stroke onset or last known well
- •4) Efforts to obtain informed consent per EFIC (exception from Informed Consent) guidelines (U.S.) or adherence to country-specific emergency research informed consent regulations (Canada, Germany, Spain, U.K., Japan)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 258
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 602
排除标准
- •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
研究者
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