EUCTR2005-005707-42-GB进行中（未招募）1 期
A single centre phase II study of Interleukin 1 receptor antagonist in the treatment of severe Traumatic Brain Injury - Interleukin-1 Receptor Antagonist in Severe Traumatic Brain Injury
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge0 个研究点目标入组 20 人开始时间: 2007年5月30日最近更新:
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
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patients with head injury aged 16-65 years with an abnormal CT scan requiring intracranial pressure monitoring.
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Head injury unlikely to survive 5 days
- •-CT evidence of above as judged by clinical team
- •-bilateral fixed and dilated pupils
- •2.follow up not possible
- •3. Not suitable for insertion of Cranial Access Device
- •-bleeding diathesis
- •4.Immunosuppression
- •-evidence of neutropenia
- •-immunosuppression secondary to immunomodulatory medications, chemotherapy or radiation therapy in the 3 months preceding study entry
- •5.Severe Renal Insufficiency or End Stage Renal Disease
- •-Defined as a Creatinine Clearance<30ml/min
- •6. Pregnancy/Nursing mothers
- •7. Known hypersensitivity to E. coli derived products
- •8. Administration of live vaccine
研究者
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