A Randomized, Open-label, Efficacy and Safety Study of Octaplex and Fresh Frozen Plasma (FFP) in Patients Under Vitamin K Antagonist Therapy With the Need for Urgent Surgery or Invasive Procedures
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Octapharma
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- RBC Transfusion Units
研究概览
简要总结
The purpose of this study is to determine whether Octaplex (human prothrombin complex concentrate) can reverse the effects of anticoagulants when compared to the standard treatment of fresh frozen plasma (FFP).
详细描述
The primary objective of the study is to demonstrate that the efficacy of Octaplex as a reversal agent in patients under vitamin K antagonist therapy with the need for urgent surgery or invasive procedures was not clinically inferior to that of FFP.
The secondary objective of the study is to investigate the safety and tolerability of Octaplex compared to FFP in patients under vitamin K antagonist therapy with the need for urgent surgery or invasive procedures.
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 or female patients at least 18 years of age.
- •Patients receiving oral anticoagulation with coumadin or warfarin derived agents.
- •Patients who have need for urgent surgery or an invasive procedure up to 8 hours after admission or identification of a patient currently hospitalized, where oral or parenteral vitamin K therapy is deemed too slow in its action for reversal of coumadin or warfarin anticoagulant effects.
- •Patients with an international normalized ratio (INR) of 2.0 or above.
- •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. In the case of unconscious and/or incapacitated patients, the willingness of the patient's legal representative for the patient to undergo the procedures laid out in the study protocol.
排除标准
- •Patients with a life expectancy of less than 48 hours (eg, patients with a Glasgow Coma Scale (GCS) equal to 3 or a head abbreviated injury score (AIS) of 6, patients requiring continuous inotropic or pressor support, patients status post-cardiac arrest).
- •Patients with a history within the last 6 months of disseminated intravascular coagulation (DIC), or hyperfibrinolysis.
- •Patients with a known congenital coagulation disorder.
- •Patients with known antiphospholipid antibody syndrome or have known lupus anticoagulant antibodies.
- •Patients with present or past specific factor inhibitor activity.
- •Patients with thrombocytopenia of < 80,000 or a history of heparin induced thrombocytopenia (HIT).
- •Patients having received heparin of any type or any non-coumadin or warfarin anticoagulant immediately prior and/or intended to be given within the first 1 hour post-infusion.
- •Patients who have received vitamin K more than 3 hours prior to the infusion of study drug.
- •Patients with a history of hypersensitivity to plasma-derived products.
- •Pregnant or nursing women.
- •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
RBC Transfusion Units
时间窗: Intra-operative; throughout the duration of operation
Total number of intra-operative units of red blood cell (RBC) given to patients
INR Response
时间窗: 15 minutes after the end of first infusion of OCTAPLEX or FFP
Number of patients who had an INR response, defined as the correction of patient's INR to \<1.5, 15 minutes after the end of first infusion with study medication
次要结局
未报告次要终点