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临床试验/CTRI/2018/04/013280
CTRI/2018/04/013280已完成不适用

“ Intracranial pressure guided management among severe traumatic brain injury patients with no surgically evacuable mass lesion;comparision between decompressive craniectomy with maximal medical management - A randomized controlled trial

King Georges Medical University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年11月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Glasgow coma scale

研究概览

简要总结

head injury is the most common cause for death in young generation all over the world. even with the best available management prognosis is bad. in our study we insert extraventricular drain in severe head injury patients and measure intra cranial pressure(ICP). even with so many studies results are not clear. mode of management is not clear. in our study icp monitoring avoided unnecessary imtervention in 30% of our patienrs. it found in our study suegical management is better than medical management

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Traumatic brain injury 1)CT scan with no evidence of surgically evacuable lesion 2)GCS ≤ 8 on admission after initial resuscitation 3)Admission within 24 hours of injury 4)Closed head trauma.

排除标准

  • GCS of 3 with bilateral fixed and dilated pupil.
  • Severe coagulopathy that is not correctable.
  • Surgically evacuable lesion on CT.
  • Previous Craniectomy.
  • Associated spinal cord injury.
  • Refusal by care takers to become a part of study.
  • Pregnancy.
  • Refusal by care takers after randomization to accept the group the patient is alloted.

结局指标

主要结局

Glasgow coma scale

时间窗: Glasgow coma scale 7 days and 3 months

次要结局

  • hospital stay. survival , decrease ICP(at discharge or death)

研究者

发起方
King Georges Medical University
申办方类型
Research institution

研究点 (1)

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