CTRI/2024/04/065004尚未招募3 期
Decompressive Craniectomy versus Hinge Craniotomy for Intracranial hypertension in Traumatic Brain Injury
National Institute of Mental Health and Neurosciences (NIMHANS)1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年5月1日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Extended Glasgow Outcome Scale (GOSE)
研究概览
简要总结
This trial aims to find which of the two surgical procedures (decompressive craniectomy, where a large bone flap is removed from the skull, versus hinge craniotomy, where the replaced bone flap is split in a way to allow expansion to accommodate the swollen brain) is superior in the management of diffuse cerebral edema causing raised intracranial pressure in closed traumatic brain injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- Male
入选标准
- •Closed head injury patients in whom brain swelling is indicative of raised intracranial pressure that is no longer controlled by medical management.
排除标准
- •Unsurvivable injury Comoborbidities that prevent surgical treatment Previous history of decompressive craniectomy (DC) or cranioplasty where further DC or hinge craniotomy cannot be done.
结局指标
主要结局
Extended Glasgow Outcome Scale (GOSE)
时间窗: 12 months from injury
次要结局
- Reduction in intracranial pressure(24 hours after the intervention (surgery) [if an ICP monitoring was done])
- Extended Glasgow Outcome Scale (GOSE)(One, three, and six months)
- Wound complications(14 days of intervention)
- Postoperative hydrocephalus(12 months after injury)
- Timing of cranioplasty (in the DC group)(12 months after injury)
- Method of storage of the bone flap in the DC group(12 months of injury)
- Duration of hospitalisation(12 months of injury)
研究者
Dhaval Shukla
National Institute of Mental Health and Neurosciences (NIMHANS)
研究点 (1)
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