NCT04352296已完成不适用
Effect of Individualized Versus Standard Blood Pressure Management During Mechanical Thrombectomy for Anterior Ischemic Stroke
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 433
- 试验地点
- 1
- 主要终点
- Number of patient with a favorable functional outcome at 3 months
研究概览
简要总结
DETERMINE is a multicenter, prospective, randomised, open, blinded end-point assessed (PROBE) trial, to evaluate two approaches of blood pressure (BP) management during mechanical thrombectomy for acute ischemic stroke due to an anterior large vessel occlusion.
详细描述
This study have to objective to evaluate the efficacy of an individualized BP control during mechanical thrombectomy (regardless of the sedation modality), by maintaining a mean arterial pressure (MAP) within 10% of the first MAP measured in the angiography suit, compared to the standard BP management, on the 3-month functional outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years old
- •Acute ischemic stroke due to an anterior large vessel occlusion: occlusion of the M1 or M2 segments of the middle cerebral artery, anterior cerebral artery (A1 segment), intracranial internal carotid artery, or tandem occlusions.
- •Indication for mechanical thrombectomy under general anesthesia or conscious sedation within the first 6 hours from symptoms onset or within the first 24 hours if DAWN or DEFUSE-3 criteria are met.
- •Affiliation to social security assurance.
排除标准
- •Contre-indication to mechanical thrombectomy
- •Intubation or induction of general anaesthesia prior to randomization
- •Acute ischemic strokes associated with a posterior circulation large vessel occlusion (basilar artery, vertebral artery, posterior cerebral artery)
- •Intra-hospital onset of acute ischemic stroke, or secondary to a medical, interventional or surgical procedure (interventional cardiology, cardiac or vascular surgery) or any post-surgery ischemic stroke.
- •Pre-existing neurological disability limiting neurological assessment at 3 months: mRS >2 at randomization.
- •Contraindication to iodinated contrast agents
- •Known pregnancy or breastfeeding woman
结局指标
主要结局
Number of patient with a favorable functional outcome at 3 months
时间窗: 3 months visit
Rankin score less than 3
次要结局
未报告次要终点
研究者
研究点 (1)
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