An Observational Cohort Study of the Risk of Thromboembolic Events Among Adult Patients Treated With KCENTRA® Compared With Plasma for Urgent Reversal of Vitamin K Antagonist Therapy in the Setting of Acute Major Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 2,238
- 试验地点
- 1
- 主要终点
- Risk of thromboembolic events (TEE) for patients without a recent history of TEE
研究概览
简要总结
This observational cohort study is designed to obtain product safety information from the routine clinical setting within large, diverse, community-based populations. In the setting of acute major bleeding in which patients are treated for Vitamin K antagonist reversal, the risk of thromboembolic events (TEE) in patients treated with Kcentra® and in patients treated with plasma will be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Aged 18 years and older at admission for VKA-associated major bleeding
- •A minimum of 365 days of continuous health plan enrollment before the index hospitalization involving acute VKA reversal treatment
- •A minimum of 365 days of continuous pharmacy benefit before the index hospitalization involving acute VKA reversal treatment
排除标准
- •Patients will be excluded from the primary analyses if they:
- •Require urgent reversal of VKA therapy in the setting of bleeding due to major trauma (eg, motor vehicle accident)
- •Requiring urgent reversal of VKA therapy for a surgical procedure unrelated to major bleeding (eg, appendicitis)
结局指标
主要结局
Risk of thromboembolic events (TEE) for patients without a recent history of TEE
时间窗: Within 45 days after the index date
The risk of confirmed thromboembolic events (TEE) will be estimated for patients without a recent history of TEE treated with Kcentra® compared to patients treated with plasma. The index date is the date of acute VKA reversal for major bleeding event.
次要结局
- Rates of use of VKA therapy after the index date(Within 90 days after the index date)
- Risk of thromboembolic events(Within 45 days after the index date)
- Risk of death from any cause(Within 45 days after the index date)