EUCTR2015-002255-10-GB进行中（未招募）1 期
INFLAMMATORY RESPONSE IN MAJOR INJURY & RECOMBINANT HUMAN ERYTHROPOIETIN (IRMINE) - A PILOT STUDY - IRMINE pilot
Abertawe Bro Morgannwg University Health Board0 个研究点目标入组 10 人开始时间: 2016年6月21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
- 10
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
- •The patient is eligible to participate in the study if they:
- •have undergone a significant blunt trauma (injury severity score =16)
- •have been admitted to ITU with an expected stay >3 days.
- •are aged between 18-64 years on admission.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •The patient will not be eligible to participate in the study if they:
- •Are pregnant (an admission pregnancy test is routine in all female trauma patients who are of child-bearing age).
- •Have a severe isolated traumatic brain injury.
- •Have any blood-borne infections e.g. HIV, hepatitis B or C.
- •Have any known malignancies.
- •Are already participating in another clinical trial.
- •Have a contra-indication to thromboprophylaxis.
- •Have contra-indications for rhEPO:-
- •oUncontrolled hypertension.
- •oKnown sensitivity to mammalian cell derived products.
- •oHypersensitivity to the active substance or to any of the excipients.
- •oPatients who have severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident (within 3 months).
- •oPatients who have developed Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin.
- •oA history of thrombo-embolic vascular events (TVEs).
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