NCT00803101已完成3 期
An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 176
- 试验地点
- 35
- 主要终点
- Percentage of Participants Achieving Hemostatic Efficacy During Surgery
研究概览
简要总结
The purpose of this study is to evaluate efficacy, safety and tolerance of Beriplex® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by vitamin K antagonists in subjects who require immediate correction of international normalized ratio (INR) because of emergency surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 and female subjects greater than or equal to 18 years,
- •Subjects currently on oral vitamin K antagonist (VKA) therapy,
- •An urgent surgical procedure is required within 24 hours of the start of investigational medicinal product (IMP),
- •Due to the nature of the procedure, withdrawal of oral VKA therapy and infusion of plasma are also indicated to reverse the VKA effect,
- •INR greater than or equal to 2 within 3 hours before start of IMP,
- •Informed consent has been obtained.
排除标准
- •Subjects requiring urgent surgical procedures where according to the surgeon's clinical judgment, an accurate estimate of blood loss is not possible (e.g., ruptured aneurysm),
- •Subjects for whom administration of intravenous vitamin K and vitamin K antagonists withdrawal alone can adequately correct the subject's coagulopathy before initiation of the urgent surgical procedure,
- •Administration of intravenous vitamin K more than 3 hours or administration of oral vitamin K more than 6 hours prior to infusion of IMP,
- •Subjects in whom lowering INR within normal range may present an unacceptable risk for a thromboembolic complication where the INR goal is to lower but not normalize the INR because of risk of a procedure-associated stroke,
- •Subjects, who despite medical management that includes close monitoring and diuretics, may not, by investigator assessment, tolerate the total volume of IMP required by the protocol,
- •Expected need for additional non-study blood products before infusion of IMP (Note: Administration of packed red blood cells is not an exclusion criterion),
- •Expected need for platelet transfusions or desmopressin before Day 10,
- •Acute trauma for which reversal of vitamin K antagonists alone would not be expected to control or resolve an acute bleeding complication and/or control the acute bleeding event,
- •Unfractionated or low molecular weight heparin use within 24 hours before randomization or potential need before completion of the procedure,
- •History of thromboembolic event, myocardial infarction, unstable angina pectoris, critical aortic stenosis, cerebral vascular accident, transient ischemic attack, severe peripheral vascular disease, disseminated intravascular coagulation within 3 months of enrollment,
- •Reversal of VKA therapy alone may not resolve the coagulopathy (eg, receiving a potent anti-platelet agent, i.e., clopidogrel or prasugrel, or advanced liver disease),
- •Known history of antiphospholipid antibody syndrome or lupus anticoagulant antibodies,
- •Suspected or confirmed serious viral or bacterial infection, e.g., meningitis, or sepsis at time of enrollment,
- •Administration of whole blood, plasma, plasma fractions or platelets within 2 weeks prior to inclusion into the study (Note: Administration of packed red blood cells is not an exclusion criterion),
- •Pre-existing progressive fatal disease with a life expectancy of less than 2 months,
- •Known inhibitors to coagulation factors II, VII, IX, or X; or hereditary protein C or protein S deficiency; or heparin-induced, type II thrombocytopenia,
- •Treatment with any other investigational medicinal product within 30 days prior to inclusion into the study,
- •Presence or history of hypersensitivity to components of the study medication,
- •Pregnant or breast-feeding women,
- •Prior inclusion in this study or any other CSL Behring sponsored Beriplex study,
- •For subjects with intracranial hemorrhage with:
- •Glasgow Coma Score <10 (see Appendix 8)
- •Modified Rankin Score > 3 prior to ICH (see Appendix 9)
- •Intracerebral hemorrhage
- •Epidural hematomas
- •Infratentorial hemorrhage
- •Subarachnoid hemorrhage (SAH) subjects with a Hunt and Hess Scale >2
- •Subdural hematomas that:
- •are judged to be an acute subdural hematoma (based on neurosurgeon review)
- •have a concurrent SAH or parenchymal contusion
结局指标
主要结局
Percentage of Participants Achieving Hemostatic Efficacy During Surgery
时间窗: From the start of infusion until the end of surgery
Hemostatic efficacy was rated as excellent, good, or poor/none, based on prespecified definitions. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where 'effective' was a hemostatic efficacy rating of "excellent" or "good," and 'non-effective' was a hemostatic efficacy rating of "poor/none".
Percentage of Participants Who Had a Rapid Decrease of the INR
时间窗: 30 minutes after the end of infusion
A rapid decrease of the INR was defined as an INR ≤ 1.3 at 30 minutes after the end of infusion. The INR is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy.
次要结局
- Transfusion of Packed Red Blood Cells (PRBCs) or Whole Blood(From the start of surgery until 24 h after the start of surgery)
- Percentage of Participants Who Received Red Blood Cells(From the start of surgery until 24 h after the start of surgery)
- Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S(From pre-infusion until 24 h after the start of infusion)
- Percentage of Participants With INR Correction at Various Times After the Start of Infusion(From the start of infusion until INR correction; calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion)
- Overall Treatment-emergent Adverse Events (TEAEs)(From the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs and from the start of infusion up to the allowed time window of the Day 45 visit for SAEs)
研究者
研究点 (35)
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