ISRCTN87370545已完成未知
Randomised Evaluation of Surgery with Craniectomy for patients Undergoing Evacuation of Acute Subdural Haematoma (RESCUE-ASDH)
Cambridge University Hospitals NHS Foundation Trust & University of Cambridge (UK)0 个研究点目标入组 463 人开始时间: 2014年7月31日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 463
研究概览
简要总结
2023 Results article in https://doi.org/10.1056/nejmoa2214172 (added 25/04/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38885989/ Cost evaluation (added 25/06/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Participant inclusion criteria as of 04/12/2018:
- •1. Adult head-injured patients (>16 years)
- •2. Acute subdural haematoma on CT*
- •3. The admitting neurosurgeon feels that the haematoma needs to beevacuated with a large bone flap (recommended size =11 cm anteroposterior diameter) either by a craniotomy or decompressive craniectomy
- •*Patients with additional lesions (e.g. intracerebral haemorrhage, contusions) can be included
- •Previous participant inclusion criteria:
- •1. Adult head-injured patients (>16 years)
- •2. Acute subdural haematoma on CT*
- •3. The admitting neurosurgeon feels that the haematoma needs to be evacuated either by a craniotomy or decompressive craniectomy (bone flap at least 11 cm in both instances )*
- •*Patients with additional lesions (e.g. intracerebral haemorrhage, contusions) can be included
排除标准
- •Participant exclusion criteria as of 04/12/2018:
- •1. Bilateral acute subdural haematomas both requiring evacuation
- •2. Previous enrolment in the RESCUE-ASDH study
- •3. Severe pre-existing physical or mental disability or severe co-morbidity which would lead to a poor outcome even if the patient made a full recovery from the head injury
- •Previous participant exclusion criteria:
- •1. Bilateral unresponsive dilated pupils of =5 mm and/or brainstem injuries on CT
- •2. Uncorrected coagulopathy
- •3. Bilateral acute subdural haematomas both requiring evacuation
- •4. Previous enrolment in the RESCUE-ASDH study
- •5. Severe pre-existing physical or mental disability or severe co-morbidity which would lead to a poor outcome even if the patient made a full recovery from the head injury
研究者
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