Department of Pharmacy, OhioHealth Grant Medical Center, 111 South Grant Avenue, Columbus, OH 43215, United States of America.
Department of Trauma, OhioHealth Grant Medical Center, 111 South Grant Avenue, Columbus, OH 43215, United States of America.
Am J Emerg Med. 2019 Oct;37(10):1907-1911. doi: 10.1016/j.ajem.2019.01.008. Epub 2019 Jan 9.
The objective of this study was to determine the effectiveness and safety of four-factor prothrombin complex concentrate (4F-PCC) for the reversal of factor Xa inhibitors in patients with traumatic intracranial hemorrhage (ICH).
This was a retrospective cohort study of patients taking factor Xa inhibitors with traumatic ICH between March 1, 2015 and August 31, 2017 at two trauma centers. The primary outcome was in-hospital mortality in patients who received 4F-PCC (4F-PCC group) compared to those who did not (no reversal group). Secondary outcomes included functional recovery, hospital and intensive care unit (ICU) length of stay (LOS), and thromboembolic complications.
There were 62 patients included in the study. Injury Severity Score (ISS) was significantly higher in the 4F-PCC group (17.6 vs. 12.1, p = 0.019). The 4F-PCC group had a significantly higher mortality (22.9% vs. 3.7%, p = 0.034) and longer ICU LOS (2.5 vs. 1.4 days, p = 0.0024). The no reversal group had a significantly higher incidence of ischemic stroke/transient ischemic attack (TIA) (0% vs. 14.8%, p = 0.019). After controlling for ISS, there was no significant difference in mortality (p = 0.20), ICU LOS (p = 0.64), or ischemic stroke/TIA (p = 0.94). There was no difference in hospital LOS, discharge disposition, final Activity Measure for Post Acute Care daily activity score, VTE, or MI.
Patients with a higher ISS received 4F-PCC preferentially, which led to an apparent mortality benefit the no reversal group. After adjusting for baseline differences between groups, there was no difference in mortality, functional recovery, hospital and ICU LOS, or thromboembolic complications.
本研究旨在确定四种凝血因子浓缩物（4F-PCC）在创伤性颅内出血（ICH）合并因子 Xa 抑制剂患者中的有效性和安全性。
这是一项回顾性队列研究，纳入了 2015 年 3 月 1 日至 2017 年 8 月 31 日在两个创伤中心服用因子 Xa 抑制剂合并创伤性 ICH 的患者。主要结局是接受 4F-PCC（4F-PCC 组）治疗的患者与未接受逆转治疗（无逆转组）的患者的院内死亡率。次要结局包括功能恢复、住院和重症监护病房（ICU）住院时间（LOS）以及血栓栓塞并发症。
共纳入 62 例患者。4F-PCC 组的损伤严重程度评分（ISS）显著较高（17.6 比 12.1，p=0.019）。4F-PCC 组死亡率明显较高（22.9%比 3.7%，p=0.034），ICU LOS 较长（2.5 比 1.4 天，p=0.0024）。无逆转组缺血性卒中和短暂性脑缺血发作（TIA）发生率显著较高（0%比 14.8%，p=0.019）。在校正 ISS 后，死亡率（p=0.20）、ICU LOS（p=0.64）或缺血性卒中和 TIA（p=0.94）均无显著差异。两组间住院 LOS、出院去向、最终急性后护理活动测量每日活动评分、静脉血栓栓塞症（VTE）或心肌梗死（MI）无差异。
ISS 较高的患者更倾向于接受 4F-PCC，这导致无逆转组死亡率明显降低。在调整组间基线差异后，死亡率、功能恢复、住院和 ICU LOS 或血栓栓塞并发症无差异。
