ISRCTN17654248进行中（未招募）2 期
Efficacy of Nitric Oxide in Stroke-2
niversity of Nottingham0 个研究点目标入组 120 人开始时间: 2021年3月31日最近更新:
适应症
试验速览
- 阶段
- 2 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
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 19/05/2022:
- •1. Adults (aged =18 years)
- •2. Presentation compatible with hyperacute stroke syndrome
- •3. One or more of the following symptoms present at time of enrolment: Dysphasia, neglect (NIHSS 1-2), hemianopia (NIHSS 1-3), or limb weakness (NIHSS on affected arm and/or leg 1-4)
- •4. Treatment can be commenced between 3 and 5 h from onset of symptoms (for patients with wake-up stroke, treatment no more than 5 h after patient awakens)
- •5. Systolic BP =120 mmHg
- •6. If a CT/MR scan has already been performed, then it shows acute intracerebral haemorrhage or ischaemic stroke, or is normal. (If a CT scan has not been performed then it should be performed as soon as possible after treatment.)
- •7. For participants who lack capacity to consent for themselves and have no relative/friend available: Waiver of consent for treatment to ensure GTN given in 3- to 5-h time-window (and thrombolysis not delayed if ischaemic stroke)
- •Previous inclusion criteria:
- •1. 120 adults (=18 years old) with presentation compatible with stroke)
- •2. Treatment 3-5 hours post ictus (or from when last seen free of stroke symptoms)
- •3. Limb weakness at time of enrolment (NIHSS on affected are and/or leg 1-4)
- •4. Systolic blood pressure (=120 mmHg)
- •5. If a CT/MR scan has already been performed, then it shows acute intracerebral haemorrhage or ischaemic stroke, or is normal
- •6. Waiver of consent for treatment to ensure GTN given in 3-5 hour time-window (and thrombolysis not delayed if ischaemic stroke)
排除标准
- •Current exclusion criteria as of 19/05/2022 (following amendment approved 18/05/2022):
- •1. mRS =4
- •2. Hypotension or shock (systolic <120 mmHg)
- •3. BP Glucose (BM stix or equivalent) <3 mmol/l
- •4. Glasgow coma scale =8
- •5. Witnessed seizure at presentation
- •6. Known life expectancy <6 months
- •7. Patient presenting with sensory symptoms only
- •8. Known stroke mimic, aneurysmal subarachnoid haemorrhage, or haemorrhage due to venous thrombosis
- •9. Known allergy to glyceryl trinitrate (Transiderm-Nitro) patch
- •10. Known sensitivity to Duoderm hydrocolloid dressing
- •11. Planned for palliative care only
- •12. Recent use of phosphodiesterase type 5 (PDE5) inhibitors, e.g., sildenafil (Viagra®)
- •13. If a CT/MR scan has already been performed, then it shows a non-stroke lesion that explains the acute presentation
- •14. Known previous enrolment in ENOS-2
- •Previous exclusion criteria as of 03/09/2021 (following amendment approved 25/08/2021):
- •1. mRS =4
- •2. Glucose (BM stix or equivalent) <3 mmol/l
- •3. Glasgow coma scale =8
- •4. Witnessed seizure at presentation
- •5. Known life expectancy <6 months
- •6. Known stroke mimic, aneurysmal subarachnoid haemorrhage, or haemorrhage due to venous
- •7. Systolic blood pressure <120 mmHg
- •8. Known allergy to glyceryl trinitrate (Transiderm-Nitro) patch
- •9. Known sensitivity to Duoderm hydrocolloid dressing
- •10. Planned for palliative care only
- •11. Known previous enrolment in ENOS-2
- •Previous exclusion criteria:
- •1. Patient from a nursing home
- •2. Glucose (BM stix or equivalent) <3 mmol/l
- •3. Glasgow coma scale =8
- •4. Witnessed seizure at presentation
- •5. Known life expectancy <6 months
- •6. Known stroke mimic, aneurysmal subarachnoid haemorrhage, or haemorrhage due to venous thrombosis
- •7. Systolic blood pressure <120 mmHg
- •8. Known allergy to glyceryl trinitrate (Transiderm-Nitro) patch
- •9. Known sensitivity to Duoderm hydrocolloid dressing
- •10. Planned for palliative care only
- •11. Known previous enrolment in ENOS-2
研究者
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