Post Marketing Observational Study on Safety of BALFAXAR® vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Octapharma
- 入组人数
- 3,574
- 试验地点
- 3
- 主要终点
- TEEs within 45 days following VKA reversal treatment
研究概览
简要总结
Post marketing observational study on safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subjects at least 18 years of age.
- •Subjects on VKA treatment.
- •Received 4F-PCC agent, BALFAXAR or Kcentra, for urgent reversal of within 48 hours prior to urgent surgery or invasive procedure.
排除标准
- •History of TEE within 90 days before receipt of VKA reversal therapy.
- •Subjects treated with VKA reversal therapy and not undergoing urgent invasive procedure.
研究组 & 干预措施
Kcentra® (500 IU)
KCENTRA will be administered by intravenous infusion at of 0.12 mL/kg/min (~3 units/kg/min) up to a maximum rate of 8.4 mL/min (~210 units/min). Dosing is individualized based on the patient's baseline International Normalized Ratio (INR) value and body weight.
干预措施: Kcentra (Drug)
BALFAXAR® (500 IU)
BALFAXAR will be administered by intravenous (IV) infusion at a rate of 0.12 mL/kg/min (~3 units/kg/min), up to a maximum rate of 8.4 mL/min (~210 units/min). Dosing is individualized based on the patient's baseline International Normalized Ratio (INR) value and body weight
干预措施: Balfaxar (Drug)
结局指标
主要结局
TEEs within 45 days following VKA reversal treatment
时间窗: 45 days
Proportion of subjects diagnosed with TEEs within 45 days following VKA reversal treatment with BALFAXAR compared to proportion of subjects diagnosed with TEEs within the same period following VKA reversal treatment with Kcentra.
次要结局
- TEEs within 7 and 14 days following VKA reversal treatment(14 days)
- Median Time to TEEs(45 days)
- All Cause Mortality(45 days)
- Median Time to All Cause Mortality(45 days)
- Rate of Fatal TEEs(45 days)