EUCTR2004-000919-26-GB进行中（未招募）1 期
Phase II, randomized, pharmokinetic, dose finding, and dose frequency determination using rt-PA in intraventricular hemorrhage - CLEAR IVH
ewcastle upon Tyne Hospitals NHS Trust0 个研究点目标入组 52 人开始时间: 2005年6月17日最近更新:
适应症
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
- 52
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
- •Spontaneous intracerebral haemorrhage < 30cc, intraventricular haemorrhage (IVH), intraventricular catheter (IVC) placed as standard care, systolic BP>90 mmHg and <185 mmHg, diastolic BP <105 mmHg, pre ICH rankin of 0 or 1, age 18-75, clot size 6 hrs after IVC placement must be within 5cc of presenting clot size, able to receive first dose within 48 hours of CT scan diagnosing IVH, symptom onset to diagnostic CT , 12 hrs.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Suspected or untreated aneurysm or arteriovenous malformation, clotting disorders, platelet count < 100,000, INR > 1.7, PT > 15s, elevated APTT, ICH enlargement in 6 hours after placement of intraventricular catheter, internal or surface bleeding, any other condition that would pose a significant hazard to the subject if investigational therapy were initiated
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