Non-activated four-factor prothrombin complex concentrate (4 F-PCC) has emerged as the preferred reversal strategy for patients on warfarin with life-threatening bleeding. Current dosing recommendations for 4 F-PCC require pre-treatment international normalized ratio (INR) and bodyweight values, resulting in ordering and administration delays. Studies have shown that alternative dosing regimens are safe and efficacious. This retrospective, single-center, pre- and post-protocol analysis was conducted to assess the efficacy of a pharmacist driven modified fixed-dose 4 F-PCC regimen versus package insert weight- and INR-based dosing regimen for warfarin reversal. The primary outcome was achievement of INR less than two. Secondary outcomes included dose and cost of 4 F-PCC, a time analysis, incidence of concomitant vitamin K administration, and incidence of thrombosis within seven days of 4 F-PCC. There were 195 patients included in the analysis, with 74 in the pre-cohort and 121 in the post-cohort. Baseline characteristics were similar between cohorts with the most common indication for warfarin use being atrial fibrillation (48.6% versus 47.1%) and reversal being intracerebral hemorrhage (68.9% versus 43.0%). Achievement of the primary endpoint occurred in 92% versus 95% (p = 0.097) of patients. A statistically significant difference was seen between cohorts regarding median dose and cost of 4 F-PCC administered (p < 0.001). Eleven thromboembolic events occurred with three events in the pre-cohort and eight events in the post-cohort (p = 0.453). A fixed-dose of 1500IU of 4 F-PCC was effective in reversing INR to less than two in most patients regardless of reversal indication with minimal thrombotic risks.

非活化四因子凝血酶原复合物浓缩物 (4 F-PCC) 已成为服用华法林且出现危及生命的出血患者的首选逆转策略。目前 4 F-PCC 的剂量建议需要治疗前国际标准化比率 (INR) 和体重值，导致订购和给药延迟。研究表明替代给药方案是安全有效的。进行这项回顾性、单中心、方案前和方案后分析是为了评估药剂师主导的改良固定剂量 4 F-PCC 方案与基于说明书体重和 INR 的剂量方案对华法林逆转的疗效。主要结果是 INR 低于 2。次要结局包括 4 F-PCC 的剂量和费用、时间分析、同时服用维生素 K 的发生率以及 4 F-PCC 7 天内血栓形成的发生率。分析包括 195 名患者，其中 74 名患者属于前队列，121 名患者属于后队列。队列之间的基线特征相似，华法林使用的最常见适应症是心房颤动（48.6％对47.1％），逆转是脑出血（68.9％对43.0％）。 92% 和 95% ( p  = 0.097) 的患者达到主要终点。在 4 F-PCC 给药的中位剂量和成本方面，各队列之间存在统计学显着差异 ( p  < 0.001)。发生了 11 例血栓栓塞事件，其中 3 例发生在前队列中，8 例发生在后队列中 ( p  = 0.453)。无论逆转指征如何，固定剂量的 4 F-PCC 1500IU 可有效将大多数患者的 INR 逆转至低于 2，且血栓形成风险最小。