Snyder Brett, Miller Taylor, McCormick Pamela, Gionfriddo Michael
{"title":"凝血酶原复合物浓缩物固定剂量与基于体重的凝血酶原复合物浓缩物剂量策略在因子 Xa 抑制剂逆转方面的比较。","authors":"Snyder Brett, Miller Taylor, McCormick Pamela, Gionfriddo Michael","doi":"10.1177/10760296241243368","DOIUrl":null,"url":null,"abstract":"<p><p><b>Background:</b> Our institution introduced fixed-dose prothrombin complex concentrate (PCC) to streamline order verification and medication administration. Previous studies using fixed-dose PCC for vitamin K antagonist reversal showed comparable efficacy to weight-based dosing. <b>Objective:</b> To compare fixed versus weight-based PCC dosing for reversal of Factor Xa Inhibitor (FXaI) effects. <b>Methods:</b> Retrospective cohort study conducted at a tertiary care academic medical center. Patients who received PCC to reverse the effects of apixaban or rivaroxaban were eligible. Subjects in the fixed-dose group (5000 units or 2000 units) were compared to weight-based PCC (50 units/kg). The primary outcome was time between order entry and medication administration. Secondary outcomes included: average PCC dose, postadministration procedures, achieved hemostasis, 30-day mortality, hospital length of stay, and adverse drug events. <b>Results:</b> 72 patients received fixed-dose PCC and 101 received weight-based PCC. Median time between order entry and administration was 4.5 min shorter in the fixed-dose group compared to weight-based (34.5 vs 39 min, <i>P</i> = .10). In patients who received fixed-dose, 79.2% achieved hemostasis versus 71.3% in the weight-based group (RR = 1.11, 95% CI = 0.94-1.32). There was no difference in the number of subsequent hemorrhage-related surgeries (29.2% vs 36.7%, RR = 0.80, 95% CI = 0.51-1.24) or mortality rate (26.4% vs 35.6%, RR = 0.73, 95% CI = 0.46-1.17). There were zero adverse drug events reported. Rates of thrombosis were 2.8% and < 1% (<i>P</i> = .57) in the fixed and weight-based groups, respectively. <b>Conclusion and Relevance:</b> The fixed-dosing strategy did not reduce time to PCC administration nor impact hemostasis or mortality. These data support that the fixed-dosing method is a viable option.</p>","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":"30 ","pages":"10760296241243368"},"PeriodicalIF":2.3000,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11075612/pdf/","citationCount":"0","resultStr":"{\"title\":\"Comparison of Fixed Versus Weight-Based Prothrombin Complex Concentrate Dosing Strategies for Factor Xa Inhibitor Reversal.\",\"authors\":\"Snyder Brett, Miller Taylor, McCormick Pamela, Gionfriddo Michael\",\"doi\":\"10.1177/10760296241243368\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b>Background:</b> Our institution introduced fixed-dose prothrombin complex concentrate (PCC) to streamline order verification and medication administration. Previous studies using fixed-dose PCC for vitamin K antagonist reversal showed comparable efficacy to weight-based dosing. <b>Objective:</b> To compare fixed versus weight-based PCC dosing for reversal of Factor Xa Inhibitor (FXaI) effects. <b>Methods:</b> Retrospective cohort study conducted at a tertiary care academic medical center. Patients who received PCC to reverse the effects of apixaban or rivaroxaban were eligible. Subjects in the fixed-dose group (5000 units or 2000 units) were compared to weight-based PCC (50 units/kg). The primary outcome was time between order entry and medication administration. Secondary outcomes included: average PCC dose, postadministration procedures, achieved hemostasis, 30-day mortality, hospital length of stay, and adverse drug events. <b>Results:</b> 72 patients received fixed-dose PCC and 101 received weight-based PCC. Median time between order entry and administration was 4.5 min shorter in the fixed-dose group compared to weight-based (34.5 vs 39 min, <i>P</i> = .10). In patients who received fixed-dose, 79.2% achieved hemostasis versus 71.3% in the weight-based group (RR = 1.11, 95% CI = 0.94-1.32). There was no difference in the number of subsequent hemorrhage-related surgeries (29.2% vs 36.7%, RR = 0.80, 95% CI = 0.51-1.24) or mortality rate (26.4% vs 35.6%, RR = 0.73, 95% CI = 0.46-1.17). There were zero adverse drug events reported. Rates of thrombosis were 2.8% and < 1% (<i>P</i> = .57) in the fixed and weight-based groups, respectively. <b>Conclusion and Relevance:</b> The fixed-dosing strategy did not reduce time to PCC administration nor impact hemostasis or mortality. These data support that the fixed-dosing method is a viable option.</p>\",\"PeriodicalId\":10335,\"journal\":{\"name\":\"Clinical and Applied Thrombosis/Hemostasis\",\"volume\":\"30 \",\"pages\":\"10760296241243368\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2024-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11075612/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical and Applied Thrombosis/Hemostasis\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/10760296241243368\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"HEMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical and Applied Thrombosis/Hemostasis","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/10760296241243368","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"HEMATOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景:我院引进了固定剂量凝血酶原复合物浓缩物(PCC),以简化医嘱验证和用药过程。之前使用固定剂量 PCC 逆转维生素 K 拮抗剂的研究显示,其疗效与基于体重的剂量相当。研究目的比较在逆转因子 Xa 抑制剂 (FXaI) 作用时使用固定剂量 PCC 与使用重量剂量 PCC 的效果。方法: 进行回顾性队列研究:在一家三级学术医疗中心进行的回顾性队列研究。接受 PCC 逆转阿哌沙班或利伐沙班疗效的患者均符合条件。固定剂量组(5000 单位或 2000 单位)的受试者与基于体重的 PCC(50 单位/公斤)进行了比较。主要结果是输入医嘱和给药之间的时间。次要结果包括:PCC 平均剂量、给药后程序、止血效果、30 天死亡率、住院时间和药物不良事件。结果72 名患者接受了固定剂量的 PCC,101 名患者接受了基于体重的 PCC。与按体重给药组相比,固定剂量组从输入医嘱到给药的中位时间缩短了 4.5 分钟(34.5 分钟 vs 39 分钟,P = 0.10)。在接受固定剂量给药的患者中,79.2% 的患者实现了止血,而按体重给药组的这一比例为 71.3%(RR = 1.11,95% CI = 0.94-1.32)。随后与出血相关的手术次数(29.2% vs 36.7%,RR = 0.80,95% CI = 0.51-1.24)或死亡率(26.4% vs 35.6%,RR = 0.73,95% CI = 0.46-1.17)没有差异。药物不良事件报告为零。固定剂量组和按体重组的血栓形成率分别为 2.8%(P = .57)。结论与意义:固定剂量策略不会缩短 PCC 给药时间,也不会影响止血或死亡率。这些数据支持固定剂量法是一种可行的选择。
Comparison of Fixed Versus Weight-Based Prothrombin Complex Concentrate Dosing Strategies for Factor Xa Inhibitor Reversal.
Background: Our institution introduced fixed-dose prothrombin complex concentrate (PCC) to streamline order verification and medication administration. Previous studies using fixed-dose PCC for vitamin K antagonist reversal showed comparable efficacy to weight-based dosing. Objective: To compare fixed versus weight-based PCC dosing for reversal of Factor Xa Inhibitor (FXaI) effects. Methods: Retrospective cohort study conducted at a tertiary care academic medical center. Patients who received PCC to reverse the effects of apixaban or rivaroxaban were eligible. Subjects in the fixed-dose group (5000 units or 2000 units) were compared to weight-based PCC (50 units/kg). The primary outcome was time between order entry and medication administration. Secondary outcomes included: average PCC dose, postadministration procedures, achieved hemostasis, 30-day mortality, hospital length of stay, and adverse drug events. Results: 72 patients received fixed-dose PCC and 101 received weight-based PCC. Median time between order entry and administration was 4.5 min shorter in the fixed-dose group compared to weight-based (34.5 vs 39 min, P = .10). In patients who received fixed-dose, 79.2% achieved hemostasis versus 71.3% in the weight-based group (RR = 1.11, 95% CI = 0.94-1.32). There was no difference in the number of subsequent hemorrhage-related surgeries (29.2% vs 36.7%, RR = 0.80, 95% CI = 0.51-1.24) or mortality rate (26.4% vs 35.6%, RR = 0.73, 95% CI = 0.46-1.17). There were zero adverse drug events reported. Rates of thrombosis were 2.8% and < 1% (P = .57) in the fixed and weight-based groups, respectively. Conclusion and Relevance: The fixed-dosing strategy did not reduce time to PCC administration nor impact hemostasis or mortality. These data support that the fixed-dosing method is a viable option.
期刊介绍:
CATH is a peer-reviewed bi-monthly journal that addresses the practical clinical and laboratory issues involved in managing bleeding and clotting disorders, especially those related to thrombosis, hemostasis, and vascular disorders. CATH covers clinical trials, studies on etiology, pathophysiology, diagnosis and treatment of thrombohemorrhagic disorders.