NCT01547078撤回2 期
A Phase 2 Clinical Study of Lyophilized Plasma in Patients With Acquired Coagulopathy Due to Liver Disease
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
A multi-center, phase 2, randomized, controlled study of the effect of lyophilized plasma in patients with liver disease.
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
- •Male or female patients at least 18 years of age.
- •Patients with liver disease.
- •Patients who have need for plasma therapy for a surgical or an invasive procedure or who have evidence of bleeding.
- •Patients with an elevated international normalized ratio due to liver disease.
- •Patients who have given written informed consent or for whom written informed consent has been obtained from the patient's legal representative on their behalf.
- •Patients able and willing to comply with the procedures laid out in the study protocol.
排除标准
- •Patients who are clinically unstable.
- •Patients who have received mediations that could interfere with results of laboratory testing.
- •Patients who have congenital or acquired coagulopathies of non-hepatic origin.
- •Pregnant or nursing women.
- •Active illicit drug use.
- •Patients participating in another clinical treatment study currently or during the past 1 month prior to study inclusion.
- •Patients previously enrolled in this study.
结局指标
主要结局
Assess and compare adverse events
时间窗: Duration of Study (Less than or equal to 7 days)
The primary safety objective is to assess the incidence of adverse events of lyophilized plasma compared to control.
次要结局
未报告次要终点
研究者
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