NCT01541098撤回2 期
A Phase II Clinical Study of Lyophilized Plasma in Patients on Warfarin
HemCon Medical Technologies, Inc0 个研究点开始时间: 2015年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Assess and Compare Adverse Events
研究概览
简要总结
This is a multi center, phase 2 randomized controlled study to determine the effect of lyophilized plasma in patients on warfarin therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving oral anticoagulation with warfarin derived agents.
- •Patients who have need for urgent surgery, an invasive procedure or identification of a patient with active bleeding where oral or parenteral vitamin K therapy is deemed too slow in its action for reversal of warfarin anticoagulant effects.
- •Patients with an elevated international normalized ratio.
排除标准
- •Patients who are clinically unstable.
- •Patients who have congenital or acquired coagulopathies (other than warfarin therapy).
- •Patients who have received medications that could interfere with the results of laboratory testing.
- •Pregnant or nursing women.
- •Patients participating in another clinical treatment study currently or during the past 1 month prior to study inclusion.
- •Patients previously enrolled in this study.
- •Active illicit drug use.
结局指标
主要结局
Assess and Compare Adverse Events
时间窗: Duration of Study (Less than or equal to 72 hours)
The primary safety objective is to assess the adverse events after infusion of lyophilized plasma compared to control.
次要结局
未报告次要终点
研究者
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