EUCTR2005-000382-19-LT进行中（未招募）不适用
Efficacy and tolerance of BERIPLEX® P/N in subjects with acquired deficiency of coagulation factors II, VII, IX and X due to oral anticoagulation - N/A
ZLB Behring GmbH0 个研究点目标入组 40 人开始时间: 2005年10月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female subjects >= 18 years
- •with anticoagulation therapy (coumarin or derivatives) in whom either an emergency surgical or an urgent invasive diagnostic intervention is indicated
- •with anticoagulation therapy (coumarin or derivatives) and acute bleedings in whom normalization of INR is indicated
- •Informed consent has been obtained
- •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
- •Treatment with any other investigational medicinal product in the last 30 days before study entry
- •Administration of whole blood, plasma or plasma fractions within the previous 2 weeks before study entry
- •Presence or history of hypersensitivity to the study medication
- •Known inhibitors to coagulation factors II, VII, IX or X
- •Known hereditary protein C deficiency
- •Preexisting progressive fatal disease/life expectancy of less than 3 months
- •Less than two weeks of stable oral anticoagulation in the intended therapeutic range in patients with a recent history of DVT or pulmonary embolism
- •Acute angina pectoris, acute thrombosis, acute myocardial infarction, acute disseminated intravascular coagulation, acute sepsis, severe ischemic vascular disorder
- •Pregnant women, women currently breast-feeding, or with the intention of breast-feeding
- •Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study (for details see 11.3 Informed consent of subject)
- •Evidence of an uncooperative attitude and/or drug addiction (including alcohol abuse)
- •Prior inclusion in this study
研究者
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