EUCTR2020-001304-42-GB进行中（未招募）1 期
Efficacy of Nitric Oxide in Stroke -2 - ENOS-2
niversity of Nottingham0 个研究点目标入组 120 人开始时间: 2020年7月10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
- 120
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
- •100 adults (=18 years) with ischaemic stroke and compatible CT (MR) scan.
- •20 adults (=18 years) with imaging-confirmed intracerebral haemorrhage (ICH) and maximum haematoma length <5cm (recruited for safety only).
- •Treatment 3-5 hours post ictus (or from when last seen free of stroke symptoms)
- •Systolic BP >120 mmHg
- •Waiver of consent for treatment to ensure GTN given in 3-5 hour time-window (and thrombolysis not delayed if ischaemic stroke).
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •Patient from a nursing home
- •Glucose (BM stix or equivalent) <3 mmol/l
- •Glasgow coma scale <8
- •Witnessed seizure at presentation
- •Known life expectancy <6 months.
- •Known stroke mimic, aneurysmal subarachnoid haemorrhage, or haemorrhage due to venous thrombosis
- •Systolic blood pressure <120 mmHg
- •Known allergy to glyceryl trinitrate (Transiderm Nitro) patch
- •Known sensitivity to Duoderm hydrocolloid dressing
- •Pregnant or breast-feeding
- •Planned for palliative care only
- •Known previous enrolment in ENOS-2
研究者
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