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临床试验/IRCT20170513033941N45
IRCT20170513033941N45已完成3 期

A clinical trial of effects of oral glibenclamide on size of brain contusions and their peripheral edema in patients with moderate and severe traumatic brain injury

Kashan University of Medical Sciences0 个研究点目标入组 70 人开始时间: 待定最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
70

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 years 至 75 years(—)
性别
All

入选标准

  • Patients aged between 18 and 75 years with documented closed head injury
  • patients with non-penetrating brain injury
  • Having brain contusions on initial brain CT scan
  • GCS: 5-13 without influence of sedations upon admission
  • Random blood sugar more than 70 mg/dl before the intervention
  • Patients without a lesion on brain CT which urges a surgical evacuation at any time of hospital admission (Surgical EDH, SDH, ICH or midline shift>5mm and decompressive craniectomy)
  • Patients without severe renal disorder from past history or Cr>2.5
  • Patients without severe liver disease from past history or total bilirubin above 1.5 times of normal value.

排除标准

  • Patients with spinal cord injury or spinal column instability with neurologic deficit.
  • Patients with INR>1.6
  • Systolic BP less than 90 mmHg on admission without respond to fluid resuscitation.
  • Pregnant women or a positive pregnancy test or those who intend to breastfeed during study days
  • Usage of warfarin, heparin, clopidogrel, LMWH within 72 hours prior to traumatic event
  • Usage of glibenclamide 72 hours prior to traumatic event
  • Patients with PaO2<60 mmHg
  • Patients with diabetes mellitus on either oral hypoglycemic agents or insulin before TBI

研究者

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