Michael Scott, Jennifer Schultheis, Shawn Kram, Jana Sigmon, Hui-Jie Lee, Keith Dombrowski
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While rapid administration of an appropriate hemostatic agent is recommended, the optimal timeframe for administration has not been identified.</p><p><strong>Purpose: </strong>The purpose of this study was to evaluate if 4-factor prothrombin complex concentrate (4F-PCC) time to administration (TTA) impacts hematoma expansion or mortality within 48 hours of ICH diagnosis in patients taking warfarin, apixaban, or rivaroxaban.</p><p><strong>Methods: </strong>This retrospective cohort study evaluated patients who received 4F-PCC for OAC-associated ICH at a 3-hospital academic health system between July 2013 and September 2019. Patients were divided into 3 cohorts based on ICH diagnosis location: (1) Emergency Department (ED), (2) inpatient, and (3) outside hospital (OSH). The primary outcome was hematoma expansion or mortality within 48 hours of ICH diagnosis.</p><p><strong>Results: </strong>Sixty-six patients were included in this study (ED: n = 53; Inpatient: n = 3; OSH: n = 10). The primary outcome occurred in 18 (27.3%) patients (48-hour hematoma expansion: n = 18; 48-hour mortality: n = 0). 4F-PCC administration timing was not significantly different between patients with and without hematoma expansion (median TTA 107 vs 115 minutes, respectively; <i>P</i> = .81).</p><p><strong>Conclusion: </strong>Time to 4F-PCC administration was not associated with 48-hour hematoma expansion or mortality in patients with OAC-associated ICH. These results may reflect delayed administration, as 4F-PCC may not have been administered early enough to influence outcomes. Further research is warranted to evaluate the clinical impact of 4F-PCC administration timing.</p>","PeriodicalId":13002,"journal":{"name":"Hospital Pharmacy","volume":" ","pages":"00185787251372052"},"PeriodicalIF":0.7000,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12460288/pdf/","citationCount":"0","resultStr":"{\"title\":\"Four-Factor Prothrombin Complex Concentrate Administration Timing in Oral Anticoagulant-Associated Intracranial Hemorrhage.\",\"authors\":\"Michael Scott, Jennifer Schultheis, Shawn Kram, Jana Sigmon, Hui-Jie Lee, Keith Dombrowski\",\"doi\":\"10.1177/00185787251372052\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Oral anticoagulant (OAC) associated intracranial hemorrhage (ICH) is associated with significant morbidity and mortality. While rapid administration of an appropriate hemostatic agent is recommended, the optimal timeframe for administration has not been identified.</p><p><strong>Purpose: </strong>The purpose of this study was to evaluate if 4-factor prothrombin complex concentrate (4F-PCC) time to administration (TTA) impacts hematoma expansion or mortality within 48 hours of ICH diagnosis in patients taking warfarin, apixaban, or rivaroxaban.</p><p><strong>Methods: </strong>This retrospective cohort study evaluated patients who received 4F-PCC for OAC-associated ICH at a 3-hospital academic health system between July 2013 and September 2019. Patients were divided into 3 cohorts based on ICH diagnosis location: (1) Emergency Department (ED), (2) inpatient, and (3) outside hospital (OSH). The primary outcome was hematoma expansion or mortality within 48 hours of ICH diagnosis.</p><p><strong>Results: </strong>Sixty-six patients were included in this study (ED: n = 53; Inpatient: n = 3; OSH: n = 10). The primary outcome occurred in 18 (27.3%) patients (48-hour hematoma expansion: n = 18; 48-hour mortality: n = 0). 4F-PCC administration timing was not significantly different between patients with and without hematoma expansion (median TTA 107 vs 115 minutes, respectively; <i>P</i> = .81).</p><p><strong>Conclusion: </strong>Time to 4F-PCC administration was not associated with 48-hour hematoma expansion or mortality in patients with OAC-associated ICH. These results may reflect delayed administration, as 4F-PCC may not have been administered early enough to influence outcomes. 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引用次数: 0
摘要
背景:口服抗凝剂(OAC)相关颅内出血(ICH)与显著的发病率和死亡率相关。虽然建议快速给药适当的止血剂,但最佳给药时间框架尚未确定。目的:本研究的目的是评估4因子凝血酶原复合物浓缩物(4F-PCC)给药时间(TTA)是否影响服用华法林、阿哌沙班或利伐沙班的脑出血诊断后48小时内血肿扩张或死亡率。方法:本回顾性队列研究评估了2013年7月至2019年9月在3家医院的学术卫生系统中接受4F-PCC治疗oac相关ICH的患者。根据ICH诊断地点将患者分为3组:(1)急诊科(ED),(2)住院,(3)院外(OSH)。主要结局为脑出血诊断后48小时内血肿扩大或死亡。结果:本研究共纳入66例患者(ED: n = 53;住院:n = 3; OSH: n = 10)。主要结局发生在18例(27.3%)患者中(48小时血肿扩大:n = 18; 48小时死亡率:n = 0)。4F-PCC给药时间在有和没有血肿扩张的患者之间无显著差异(中位TTA分别为107分钟和115分钟;P = 0.81)。结论:oac相关性脑出血患者给予4F-PCC的时间与48小时血肿扩张或死亡率无关。这些结果可能反映了延迟给药,因为4F-PCC可能没有足够早地给药以影响结果。需要进一步的研究来评估4F-PCC给药时间的临床影响。
Background: Oral anticoagulant (OAC) associated intracranial hemorrhage (ICH) is associated with significant morbidity and mortality. While rapid administration of an appropriate hemostatic agent is recommended, the optimal timeframe for administration has not been identified.
Purpose: The purpose of this study was to evaluate if 4-factor prothrombin complex concentrate (4F-PCC) time to administration (TTA) impacts hematoma expansion or mortality within 48 hours of ICH diagnosis in patients taking warfarin, apixaban, or rivaroxaban.
Methods: This retrospective cohort study evaluated patients who received 4F-PCC for OAC-associated ICH at a 3-hospital academic health system between July 2013 and September 2019. Patients were divided into 3 cohorts based on ICH diagnosis location: (1) Emergency Department (ED), (2) inpatient, and (3) outside hospital (OSH). The primary outcome was hematoma expansion or mortality within 48 hours of ICH diagnosis.
Results: Sixty-six patients were included in this study (ED: n = 53; Inpatient: n = 3; OSH: n = 10). The primary outcome occurred in 18 (27.3%) patients (48-hour hematoma expansion: n = 18; 48-hour mortality: n = 0). 4F-PCC administration timing was not significantly different between patients with and without hematoma expansion (median TTA 107 vs 115 minutes, respectively; P = .81).
Conclusion: Time to 4F-PCC administration was not associated with 48-hour hematoma expansion or mortality in patients with OAC-associated ICH. These results may reflect delayed administration, as 4F-PCC may not have been administered early enough to influence outcomes. Further research is warranted to evaluate the clinical impact of 4F-PCC administration timing.
期刊介绍:
Hospital Pharmacy is a monthly peer-reviewed journal that is read by pharmacists and other providers practicing in the inpatient and outpatient setting within hospitals, long-term care facilities, home care, and other health-system settings The Hospital Pharmacy Assistant Editor, Michael R. Cohen, RPh, MS, DSc, FASHP, is author of a Medication Error Report Analysis and founder of The Institute for Safe Medication Practices (ISMP), a nonprofit organization that provides education about adverse drug events and their prevention.