Michael Scott, Jennifer Schultheis, Shawn Kram, Jana Sigmon, Hui-Jie Lee, Keith Dombrowski
{"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. 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":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Hospital Pharmacy","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/00185787251372052","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
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.