From the Division of Trauma, Critical Care, Emergency Surgery, and Burns, Department of Surgery (F.J., H.A., T.O'K., M.K., E.R.Z., M.H., M.Z., N.K., B.J.), College of Medicine, University of Arizona, Tucson, Arizona.
J Trauma Acute Care Surg. 2018 Jul;85(1):18-24. doi: 10.1097/TA.0000000000001938.
Coagulopathy is a common complication after severe trauma. The efficacy of 4-factor prothrombin complex concentrate (4-PCC) as an adjunct to fresh frozen plasma (FFP) in reversal of coagulopathy of trauma (COT) has not been studied. The aim of our study is to compare 4-PCC + FFP versus FFP alone for the treatment of COT.
We reviewed all trauma patients older than 18 years who received PCC + FFP or FFP alone at our Level I trauma center from 2015 to 2016. We excluded patients on preinjury oral anticoagulants. Patients were divided into two groups (4-PCC + FFP: FFP alone) and were matched in a 1:2 ratio using propensity score matching for demographics, vital and injury parameters, and initial international normalized ratio (INR). COT was defined as admission INR > 1.5. Corrected INR was defined as an INR of 1.5 or less. Outcome measures were time to correction of INR, packed red blood cells units transfused, thromboembolic complications, and mortality.
We analyzed 516 trauma patients, of which 120 patients (4-PCC + FFP: 40, FFP: 80) were matched. Mean age was 58 ± 20 years; 60% were male, median Injury Severity Score was 29 (14-38). Mechanism of injury was blunt in 87% patients. 4-PCC + FFP was associated with an accelerated correction of INR (373 minutes vs. 955 minutes; p = 0.001), a decrease in packed red blood cells units (7 units vs. 9 units; p = 0.04), and FFP units (5 units vs. 7 units; p = 0.03) transfused compared to FFP alone. 4-PCC + FFP was associated with a lower mortality (25% vs. 33% p = 0.04) compared with FFP alone; however, there was no difference in the thromboembolic complications (2.5% vs. 1.2%, p = 0.5) between the two groups. Administration of PCC + FFP led to an earlier correction of the INR compared with FFP alone.
Results of our study demonstrated that the use of 4-PCC in conjunction with FFP is associated with the rapid reversal of INR and reduction in transfusion requirements as compared with FFP alone. Four-factor PCC as a component therapy along with FFP is superior to FFP alone for the reversal of COT.
Therapeutic studies, level IV.
凝血障碍是严重创伤后的常见并发症。4 因子凝血酶原复合物浓缩物（4-PCC）作为新鲜冷冻血浆（FFP）辅助物逆转创伤性凝血病（COT）的疗效尚未得到研究。我们研究的目的是比较 4-PCC+FFP 与单独使用 FFP 治疗 COT。
我们回顾了 2015 年至 2016 年在我们的 I 级创伤中心接受 PCC+FFP 或单独 FFP 的年龄大于 18 岁的所有创伤患者。我们排除了在受伤前服用口服抗凝剂的患者。患者分为两组（4-PCC+FFP：单独 FFP），并使用倾向评分匹配进行了 1:2 的匹配，以匹配人口统计学、生命体征和损伤参数以及初始国际标准化比值（INR）。COT 定义为入院 INR＞1.5。校正 INR 定义为 INR 为 1.5 或更低。观察指标为 INR 校正时间、输红细胞单位、血栓栓塞并发症和死亡率。
我们分析了 516 名创伤患者，其中 120 名患者（4-PCC+FFP：40，FFP：80）进行了匹配。平均年龄为 58±20 岁；60%为男性，中位数损伤严重度评分 29（14-38）。87%的患者为钝器伤。与单独使用 FFP 相比，4-PCC+FFP 可加速 INR 校正（373 分钟 vs. 955 分钟；p=0.001）、减少输红细胞单位（7 单位 vs. 9 单位；p=0.04）和 FFP 单位（5 单位 vs. 7 单位；p=0.03）。与单独使用 FFP 相比，4-PCC+FFP 组死亡率较低（25% vs. 33%，p=0.04）；然而，两组之间血栓栓塞并发症无差异（2.5% vs. 1.2%，p=0.5）。与单独使用 FFP 相比，使用 PCC+FFP 可更快地纠正 INR。
我们的研究结果表明，与单独使用 FFP 相比，使用 4-PCC 联合 FFP 可迅速逆转 INR，并减少输血需求。与单独使用 FFP 相比，4 因子 PCC 作为一种联合治疗方法联合 FFP 可更好地逆转 COT。
治疗研究，IV 级。
