ISRCTN80782810已完成未知
A randomised, double blind, placebo-controlled trial of a two-week course of dexamethasone for adult patients with a symptomatic Chronic Subdural Haematoma (Dex-CSDH trial)
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge0 个研究点目标入组 748 人开始时间: 2015年8月7日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 748
研究概览
简要总结
- 2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30514400 2. 2019 statistical analysis plan in ncbi.nlm.nih.gov/pubmed/31822298 (added 12/12/2019) 3. 2020 results in https://pubmed.ncbi.nlm.nih.gov/33326713/ (added 17/12/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Informed consent
- •2. Adults aged 16 or older
- •3. Symptomatic cSDH confirmed on cranial imaging (predominantly hypodense or isodense crescentic collection along the cerebral convexity on CT)
排除标准
- •1. Patients who have already undergone surgical intervention for a cSDH during the same index admission
- •2. Condition with conditions where steroids are clearly contra-indicated (i.e. active infections)
- •3. Already on steroids
- •4. Enrolment in same study within last 12 months
- •5. Time interval from the time of admission to NSU to initiation of trial medication exceeds 72 hours
- •6. cSDH in presence of CSF shunt
研究者
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