AI Article Synopsis
- The study focused on how the approval of prothrombin complex concentrates (PCC) impacted the treatment of intracerebral hemorrhage related to vitamin K antagonists between January 2010 and June 2021.
- Researchers compared two patient groups: one treated with discretionary dosing before PCC's approval and another with the approved manufacturer's recommended regimen afterward.
- Results showed that the recommended dose group had a more significant correction in international normalized ratio (INR) levels and received higher doses of PCC, but there were no notable differences in clinical outcomes like bleeding, thromboembolic events, or mortality rates between the two groups.
Article 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.
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| http://dx.doi.org/10.1016/j.jstrokecerebrovasdis.2022.106861 | DOI Listing |
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