NCT05517109已完成不适用
The Influence of Different Hemodynamic Parameters in First 24 Hours After Intravenous Thrombolysis on Acute Ischemic Stroke Outcomes: a Randomised Clinical Trial
Northern State Medical University2 个研究点 分布在 2 个国家目标入组 90 人开始时间: 2022年3月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Modified Rankin Scale score
研究概览
简要总结
The investigators are suggtesting that lower goals of systolic blood pressure after intravenous thrombolysis may reduce the risk of hemorrhagic complications and improve functional outcomes after acute ischemic stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Inclusion сriteria:
- •ischemic stroke diagnosis
- •performed intravenous thrombolysis (including "wake up stroke")
- •systolic blood pressure >140 mmHg
- •informed consent or council of physician agreement
排除标准
- •absence of informed consent or council of physician agreement
- •pregnancy
- •patients participainting in other clinical trial in the last 90 days
- •any absolute contraindications to intravenous thrombolysis
- •Сompletion criteria:
- •failure to achieve hemodynamic goal for 20 minutes before the start of intravenous thrombolysis
- •failure to achieve hemodynamic goal for 60 minutes in first 24 hours after intravenous thrombolysis
- •relative arterial hypotension (SBP <100 mmHg for 60 minutes in first 24 hours after intravenous thrombolysis)
- •unfavorable effect development (e.g. seizures, angioedema)
- •informed consent is retracted
结局指标
主要结局
Modified Rankin Scale score
时间窗: 90 day after intravenous thrombolysis
Fucntional outcome (Modified Rankin Scale) will be assesed by telephone interview. Score from 0 to 6. Higher scores mean a worse outcome.
Mortality rate
时间窗: At 90 day after intravenous thrombolysis
Rate of symptomatic intracranial hemorrhage
时间窗: 7 days after intravenous thrombolysis
Symptomatic intracranial hemorrhage (sICH) according to SITS-MOST study description of sICH
次要结局
- Lengths of stay in ICU(at 90 day after intravenous thrombolysis)
- Rate of acute kidney injury(28 day after intravenous thrombolysis or at discharge)
- Change in National Institutes of Health Stroke Scale (NIHSS)(at 28 day after intravenous thrombolysis)
- Rate of all Intracranial hemorrhage(7 days after intravenous thrombolysis)
- Lengths of stay in hospital(at 90 day after intravenous thrombolysis)
研究者
研究点 (2)
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