EUCTR2017-004698-15-BE进行中（未招募）1 期
Brain Injury and Ketamine: a prospective, randomized controlled double blind clinical trial to study the effects of ketamine on Therapy Intensity Level and intracranial pressure in acute brain injury patients. - BIKe-study
Z Leuven / KU Leuven0 个研究点目标入组 100 人开始时间: 2020年10月19日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- 性别
- All
入选标准
- •* Traumatic brain injury patients
- •* Age = 18 years
- •* Admitted to the ICU
- •* Within 72 hours after admission to the initial hospital:
- •1)ICP monitor in place (parenchymal probe, ventricular catheter, or both)
- •2)Requiring sedation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •* Known pregnancy and/or lactation
- •* Imminent or actual brain death upon inclusion
- •* Allergy or intolerance to the study medication
- •* Pre-existing neurocognitive disorders, pre-existing congenital or non-congenital brain dysfunction.
- •* Inability to obtain informed consent
- •* Inclusion in an IMP-RCT of which the PI indicates that co-inclusion specifically in the BIKe study is prohibited.
- •* Therapy restriction code upon inclusion.
- •* Porphyria
- •* Glaucoma
研究者
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