NCT00708435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 Coumarin Derivatives in Subjects With Acute Major Bleeding
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 216
- 试验地点
- 69
- 主要终点
- Percentage of Participants Who Had a Rapid Decrease of the International Normalized Ratio (INR)
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 coumarin derivatives in subjects who require immediate correction of INR (International Normalized Ratio)and to stop an acute major bleeding.
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 ≥ 18 years
- •Subjects who have received oral vitamin K-antagonist therapy
- •Subjects who have acute major bleeding, defined as one of the following: life-threatening or potentially life-threatening, acute bleeding associated with a fall in hemoglobin (Hb) level ≥ 2g/dL, bleeding requiring blood product transfusion
- •INR ≥ 2 within 3 hours before start of study treatment
- •Informed consent has been obtained
排除标准
- •Expected survival of less than 3 days, or expected surgery in less than 1 day
- •Acute trauma for which reversal of vitamin K antagonists alone would not be expected to control the acute bleeding event
- •Use of unfractionated or low molecular weight heparin use from 24 hours prior to enrollment or expected need within 24 hours after start of infusion
- •For patients with ICH: Glasgow coma score (GCS) < 7; intracerebral hematoma volume > 30cc as assessed by ABC/21; for subdural hematomas: maximum thickness ≥ 10 mm, midline shift ≥ 5 mm; for subarachnoid hemorrhage: any evidence of hydrocephalus; infratentorial ICH location; epidural hematomas; intraventricular extension of hemorrhage; modified Rankin score (mRS) of >3 prior to ICH
- •History of thrombotic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within 3 months of enrollment
- •Known history of antiphospholipid antibody syndrome or lupus anticoagulant antibodies
- •Suspected or confirmed sepsis at time of enrollment
- •Administration of whole blood, plasma, plasma fractions or platelets within 2 weeks prior to inclusion into the study
- •Large blood vessel rupture (e.g. in advanced cancer patient)
- •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
研究组 & 干预措施
Beriplex® P/N
Experimental
干预措施: Beriplex® P/N (Kcentra) (Biological)
Fresh frozen plasma
Active Comparator
干预措施: Fresh frozen plasma (Biological)
结局指标
主要结局
Percentage of Participants Who Had a Rapid Decrease of the International Normalized Ratio (INR)
时间窗: 30 minutes after end of infusion
A rapid decrease of the international normalized ratio (INR) was defined as an INR ≤ 1.3 at 30 minutes after the end of the 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.
Percentage of Participants Achieving Hemostatic Efficacy of Stopping an Ongoing Major Bleed
时间窗: At 1 and 4 hours after the end of infusion
Hemostatic efficacy was determined by a blinded independent board as excellent, good, or poor/none, based on prespecified definitions. Assessments of visible or non-visible musculoskeletal bleeding were made at 1 and 4 hours after the end of infusion. 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".
次要结局
- 45-Day All-cause Mortality(Until Day 45)
- Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S(From preinfusion until 24 h after the start of infusion)
- Percentage of Participants With INR Correction at Various Times After Randomization(From randomization until INR correction; calculated at 2.5, 3, 5, 8, 14, and 26 h after randomization.)
- Use of Other Blood Products and Hemostatic Agents(From the start of infusion until 24 h after the start of infusion)
- Percentage of Participants Who Had Hemostatic Efficacy for Visible or Non-visible Musculoskeletal Bleeding(At 3 and 6 hours after the start of infusion)
- Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for Beriplex(Before infusion and up to 3 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.)
- Transfusion of Red Blood Cells(From the start of infusion until 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 (69)
Loading locations...
相似试验
已完成
3 期
An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical ProcedureReversal of CoagulopathyNCT00803101CSL Behring176
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/AAcquired deficiency of coagulation factors II, VII, IX and X due to oral anticoagulation requiring an immediate reversal of anticoagulant effect (i.e. emergency surgery or acute bleeding).MedDRA version: 7.1Level: LLTClassification code 10000534EUCTR2005-000382-19-LTZLB Behring GmbH40
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/AAcquired deficiency of coagulation factors II, VII, IX and X due to oral anticoagulation requiring an immediate reversal of anticoagulant effect (i.e. emergency surgery or acute bleeding).MedDRA version: 7.1Level: LLTClassification code 10000534EUCTR2005-000382-19-ATZLB Behring GmbH40
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/AAcquired deficiency of coagulation factors II, VII, IX and X due to oral anticoagulation requiring an immediate reversal of anticoagulant effect (i.e. emergency surgery or acute bleeding).MedDRA version: 7.1Level: LLTClassification code 10000534EUCTR2005-000382-19-DEZLB Behring GmbH40
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/AAcquired deficiency of coagulation factors II, VII, IX and X due to oral anticoagulation requiring an immediate reversal of anticoagulant effect (i.e. emergency surgery or acute bleeding).MedDRA version: 7.1Level: LLTClassification code 10000534EUCTR2005-000382-19-HUZLB Behring GmbH40