jRCTs051200076招募中不适用
The investigator-initiated international clinical trial on efficacy and safety of recombinant factor VIIa for hyperacute intracerebral hemorrhage (FASTEST)
未提供0 个研究点目标入组 446 人开始时间: 2022年7月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 446
- 主要终点
- ordinal modified Rankin Scale (mRS) at 180 days
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age old over 至 80age old under（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
ordinal modified Rankin Scale (mRS) at 180 days
时间窗: 180 days
0-2, 3, and 4-6
distribution of the ordinal mRS at 90 days
时间窗: 90 days
0-2, 3, and 4-6
life-threatening thromboembolic complications
时间窗: during the first four days after completion of study drug
acute myocardial infarction, acute cerebral infarction, and acute pulmonary embolism
次要结局
- 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)
研究者
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