Abstract：
Controversy and variation exist in surgical management for acute epidural haematoma (AEDH). Although craniotomy for AEDH is conventionally employed, no specific evaluation on the necessity of decompressive craniectomy (DC) followed by AEDH evacuation has been performed.
This is a multicentre prospective, phase III observational study that evaluates different surgical managements for the AEDH. Patients of both genders, aged 18-65 years, presenting to the emergency room with a clinical and radiological diagnosis of AEDH, complying with other inclusion and exclusion criteria, are enrolled. Clinical information, including diagnosis of AEDH, radiological information, treatment procedures and follow-up data of 1, 3 and 6 months post-injury, is collected on 2000 eligible patients among 263 hospitals in China. Recruitment for the study started in April 2021, and inclusion will be continued until the sample size is obtained, expected is an inclusion period of 24 months. The interventions of concern are surgical treatments for AEDH, including craniotomy and DC. The primary outcome is the Glasgow Outcome Score-Extended 6 months post-injury. Secondary outcomes include the incidence of postoperative cerebral infarction, the incidence of additional craniocerebral surgery and other evaluation indicators within 6 months post-injury.
The study protocol has been approved by the ethics committee and institutional review board of Renji Hospital, School of Medicine, Shanghai Jiao Tong University. All study investigators strictly follow the Declaration of Helsinki and Human Biomedical Research Ethical Issues. Signed written informed consent will be obtained from all enrolled patients. The trial results will be disseminated through academic conferences and published in peer-reviewed journals.
NCT04229966.
This is a multicentre prospective, phase III observational study that evaluates different surgical managements for the AEDH. Patients of both genders, aged 18-65 years, presenting to the emergency room with a clinical and radiological diagnosis of AEDH, complying with other inclusion and exclusion criteria, are enrolled. Clinical information, including diagnosis of AEDH, radiological information, treatment procedures and follow-up data of 1, 3 and 6 months post-injury, is collected on 2000 eligible patients among 263 hospitals in China. Recruitment for the study started in April 2021, and inclusion will be continued until the sample size is obtained, expected is an inclusion period of 24 months. The interventions of concern are surgical treatments for AEDH, including craniotomy and DC. The primary outcome is the Glasgow Outcome Score-Extended 6 months post-injury. Secondary outcomes include the incidence of postoperative cerebral infarction, the incidence of additional craniocerebral surgery and other evaluation indicators within 6 months post-injury.
The study protocol has been approved by the ethics committee and institutional review board of Renji Hospital, School of Medicine, Shanghai Jiao Tong University. All study investigators strictly follow the Declaration of Helsinki and Human Biomedical Research Ethical Issues. Signed written informed consent will be obtained from all enrolled patients. The trial results will be disseminated through academic conferences and published in peer-reviewed journals.
NCT04229966.
摘要：
急性硬膜外血肿（AEDH）的手术治疗存在争议和差异。尽管AEDH的开颅术通常被采用，没有对开颅减压术(DC)后进行AEDH疏散的必要性进行具体评估.
这是一个多中心的前瞻性，评估AEDH不同手术管理的III期观察性研究。男女患者，18-65岁,向急诊室提供AEDH的临床和放射学诊断，符合其他纳入和排除标准，已注册。临床信息,包括AEDH的诊断，放射学信息，伤后1、3和6个月的治疗程序和随访数据，收集了中国263家医院中的2000名合格患者。该研究的招募始于2021年4月，并将继续纳入研究，直到获得样本量为止。预计纳入期为24个月。关注的干预措施是AEDH的手术治疗，包括开颅手术和DC.主要结果是受伤后6个月的格拉斯哥预后评分延长。次要结果包括术后脑梗死的发生率，伤后6个月内增加颅脑手术发生率等评价指标。
研究方案已获得仁济医院伦理委员会和机构审查委员会的批准，医学院,上海交通大学。所有研究人员都严格遵守赫尔辛基宣言和人类生物医学研究伦理问题。签署的书面知情同意书将从所有登记的患者获得。试验结果将通过学术会议传播，并在同行评审的期刊上发表。
NCT04229966。
这是一个多中心的前瞻性，评估AEDH不同手术管理的III期观察性研究。男女患者，18-65岁,向急诊室提供AEDH的临床和放射学诊断，符合其他纳入和排除标准，已注册。临床信息,包括AEDH的诊断，放射学信息，伤后1、3和6个月的治疗程序和随访数据，收集了中国263家医院中的2000名合格患者。该研究的招募始于2021年4月，并将继续纳入研究，直到获得样本量为止。预计纳入期为24个月。关注的干预措施是AEDH的手术治疗，包括开颅手术和DC.主要结果是受伤后6个月的格拉斯哥预后评分延长。次要结果包括术后脑梗死的发生率，伤后6个月内增加颅脑手术发生率等评价指标。
研究方案已获得仁济医院伦理委员会和机构审查委员会的批准，医学院,上海交通大学。所有研究人员都严格遵守赫尔辛基宣言和人类生物医学研究伦理问题。签署的书面知情同意书将从所有登记的患者获得。试验结果将通过学术会议传播，并在同行评审的期刊上发表。
NCT04229966。
