ACTRN12607000567426招募中4 期
An open label, phase IV clinical trial examining the efficacy of Prothrombinex-VF alone verses Prothrombinex-VF combined with fresh frozen plasma in patients who require Warfarin reversal.
Frankston Hospital0 个研究点目标入组 40 人开始时间: 2007年11月5日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 /A（—）
- 性别
- All
入选标准
- •1. Patients who are on Warfarin therapy with an asymptomatic INR >9 where the treating clinician wishes to reverse the effects of the drug
- •2. Any clinically significant bleeding where Warfarin induced coagulopathy is considered a contributing factor and an INR of >2.5 where Warfarin reversal is considered important by the clinician
- •3. Pre surgery if INR >2.5 on the day of surgery and the clinician requires reversal of the effects of Warfarin
- •4. Patient is = 18 years of age.
- •5. Patients that are able to understand and apply with study protocol requirements and instructions and intends to complete the study as planned.
- •6. Patient signs and dates written informed consent.
排除标准
- •1.Active bleeding requiring blood transfusion.
- •2.Patients with a known allergy to prothrombin complex concentrates or fresh frozen plasma.
- •3.Participation in another pharmacotherapeutic study within 30 days.
研究者
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