Evaluation of 4-Factor PCC in DOAC-associated Intracranial Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Determine safety and effectiveness of 4F-PCC
研究概览
简要总结
Intracranial hemorrhage (ICH) can occur due to traumatic and spontaneous events.1 The incidence of non-traumatic, spontaneous ICH is approximately 40,000 to 67,000 cases per year while the incidence of traumatic brain injury (TBI) is nearly 1.7 million annually
详细描述
The authors found that AC use preinjury was associated with ICH progression, immediate neurosurgery intervention, and death after initial scan. AC use has also been associated with worse functional outcomes, and patients are less likely to be discharged home compared to those without AC use prior to injury.6 With increasing prevalence of AC, hospitals are seeing admissions for ICH, making knowledge of optimal AC reversal essential.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• ≥18 years of age
- •ICH (traumatic and spontaneous)
- •Administration of at least one dose of 4F-PCC
- •Admitted to the MHS between July 1, 2018 and May 30, 2023
- •Rivaroxaban or apixaban use prior to admission
排除标准
- •• Warfarin or dabigatran use prior to admission
- •Prisoners
- •Pregnancy
- •<18 years of age
结局指标
主要结局
Determine safety and effectiveness of 4F-PCC
时间窗: 12 hours
fixed-dose 4F-PCC is safe and effective in patients with DOAC-associated ICH when compared to weight-based dosing.
次要结局
未报告次要终点