Abstract
Objectives
This study aimed to determine the impact of the approval of prothrombin complex concentrates
on the treatment of vitamin K antagonist-related intracerebral hemorrhage.
Materials and Methods
We retrospectively studied all patients with vitamin K antagonist-related intracerebral
hemorrhage treated with prothrombin complex concentrate at our institutes between
January 2010 and June 2021. Before approval, prothrombin complex concentrate was administered
as either 500 or 1000 IU at the physician's discretion (previous dose group). After
approval, we adopted the manufacturer's recommended regimen (recommended dose group).
The primary outcome was post-administration international normalized ratio. Secondary
outcomes were the amount of prothrombin complex concentrate administered and proportion
of post-administration international normalized ratio <1.5, hematoma expansion, thrombotic
events within 30 days, modified Rankin scale 0–3 at discharge, and in-hospital mortality.
Results
Thirty-two and 19 patients in the previous and recommended dose groups, respectively,
were included. The post-administration international normalized ratio significantly
differed between groups. The prothrombin complex concentrate dose and proportion of
patients achieving post-administration international normalized ratio <1.5 were significantly
higher in the recommended dose group than in the previous dose group (1500 IU vs.
500 IU, p<0.001 and 100% vs. 68%, p = 0.008). The proportions of hematoma expansion, thromboembolic events, modified
Rankin scale 0-3, and mortality did not differ between groups.
Conclusion
After prothrombin complex concentrate approval, prothrombin time-international normalized
ratio correction was more effective with a significant increase in the prothrombin
complex concentrates dose for vitamin K antagonist-associated intracerebral hemorrhage;
however, there was no apparent difference in clinical outcomes.
Key Words
Abbreviations:
VKA (vitamin K antagonist), ICH (intracerebral hemorrhage), pcc (prothrombin complex concentrate)To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Journal of Stroke and Cerebrovascular DiseasesAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Hemorrhagic complications of anticoagulant and thrombolytic treatment: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition).Chest. 2008; 133: 257S-298S
- Bleeding risk assessment and management in atrial fibrillation patients: a position document from the European Heart Rhythm Association, endorsed by the European Society of Cardiology Working Group on Thrombosis.Europace. 2011; 13: 723-746
- Warfarin, hematoma expansion, and outcome of intracerebral hemorrhage.Neurology. 2004; 63: 1059-1064
- Death and disability from warfarin-associated intracranial and extracranial hemorrhages.Am J Med. 2007; 120: 700-705
- Predisposing factors for enlargement of intracerebral hemorrhage in patients treated with warfarin.Thromb Haemost. 2003; 89: 278-283
- Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American heart association/American stroke association.Stroke. 2015; 46 (3rd): 2032-2060
- European Stroke Organization (ESO) guidelines for the management of spontaneous intracerebral hemorrhage.Int J Stroke. 2014; 9: 840-855
- Guideline for reversal of antithrombotics in intracranial hemorrhage: a statement for healthcare professionals from the neurocritical care society and society of critical care medicine.Neurocrit Care. 2016; 24 (III): 6-46
- 2022 guideline for the management of patients with spontaneous intracerebral hemorrhage: a guideline from the American Heart Association/American Stroke Association.Stroke. 2022; 53: e282-e361
- Optimal dose of prothrombin complex concentrate for acute reversal of oral anticoagulation.Thromb Res. 2005; 115: 455-459
- Factors affecting the prognosis in thalamic hemorrhage.Stroke. 1983; 14: 493-500
- Cerebral microbleeds and the effect of intensive blood pressure reduction on hematoma expansion and functional outcomes: a secondary analysis of the ATACH-2 randomized clinical trial.JAMA Neurol. 2018; 75: 850-859
- Regression Modeling Strategies: with Applications to Linear Models, Logistic Regression, and Survival Analysis.springer, New York2001
- Time course of early postadmission hematoma expansion in spontaneous intracerebral hemorrhage.Stroke. 2014; 45: 994-999
- High-dose s4-factor prothrombin complex concentrate for warfarin-induced intracranial hemorrhage.Neurohospitalist. 2020; 10: 16-21
- Fixed versus variable dosing of prothrombin complex concentrate in vitamin K antagonist-related intracranial hemorrhage: a retrospective analysis.Neurocrit Care. 2017; 26: 64-69
- Role of prothrombin complex concentrates in reversing warfarin anticoagulation: a review of the literature.Am J Hematol. 2008; 83: 137-143
- Four-factor prothrombin complex concentrate versus plasma for rapid vitamin K antagonist reversal in patients needing urgent surgical or invasive interventions: a phase 3b, open-label, non-inferiority, randomized trial.Lancet. 2015; 385: 2077-2087
- Thromboembolic events after vitamin k antagonist reversal with 4-factor prothrombin complex concentrate: exploratory analyses of two randomized, plasma-controlled studies.Ann Emerg Med. 2016; 67: 96-105
- Management of intracranial hemorrhage associated with anticoagulant therapy.Surg Neurol. 1995; 44 (discussion 443): 438-442
Article Info
Publication History
Published online: October 27, 2022
Accepted:
October 24,
2022
Received:
September 2,
2022
Identification
DOI: https://doi.org/10.1016/j.jstrokecerebrovasdis.2022.106861
Copyright
© 2022 Elsevier Inc. All rights reserved.
