JPRN-jRCTs051230153招募中2 期
A Expoloratory Study to evaluate the Efficacy and Safety of Hydrocortisone for the Prevention of Symptomatic Vasospasm after Subarachnoid Hemorrhage.
ozumi Yoichi0 个研究点目标入组 100 人开始时间: 2023年12月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
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
- 年龄范围
- >= 18age old 至 < 86age old（—）
- 性别
- All
入选标准
- •Patients who meet all of the following criteria are eligible.
- •1. Patients aged between 18 and 85 at the time of informed consent
- •2. Patients with subarachnoid hemorrhage due to cerebral aneurysm rupture
- •3. Aneurysm neck clipping or coil embolization was performed for ruptured cerebral aneurysm within 24 hours after onset and up to 4 days after onset
- •4. Patients who have obtained voluntary written consent from the patient and his/her legal representative to participate in this study (However, if the principal investigator or sub-investigator determines that the patient lacks the capacity to consent due to a disorder of consciousness, etc., only a representative legal representative will be allowed to consent.)
排除标准
- •1. Patients who are not independent in daily life before onset of subarachnoid hemorrhage (modified Rankin Scale score 2 or higher)
- •2. Patients with the most severe subarachnoid hemorrhage (WFNS Grade V)
- •3. Patients with severe cardiac dysfunction (heart failure, arrhythmia, etc.) or renal dysfunction
- •4. Patients with hypersensitivity to drugs such as allergies
- •5. Pregnant women, possibly pregnant women, or breast-feeding patients
- •6. Patients who have participated in another clinical trial and are currently recieving therapeutic drugs in that clinical trial
- •7. Patients who are contraindicated for hydrocortisone administration, patients who have a history of hypersensitivity to the ingredients of this drug, and patients who are receiving desmopressin acetate hydrate (nocturia due to nocturia in men)
- •8. Patients who have been receiving corticosteroids before the onset of subarachnoid hemorrhage
- •9. Patients with acute myocardial infarction, bacterial or fungal infections for whom there are no effective antibiotics
- •10. In addition, patients who are judged to be inappropriate by the doctor in charge of each facility in this clinical study
研究者
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