Utility of four–factor prothrombin complex concentrate for rapid vitamin K reversal in patients with intracranial hemorrhage

  • Aizawa Yuki
    Department of Neurosurgery, Tokyo Medical and Dental University
  • Inaji Motoki
    Department of Neurosurgery, Tokyo Medical and Dental University
  • Takahashi Satoru
    Department of Neurosurgery, Tokyo Medical and Dental University
  • Ishikawa Mariko
    Department of Neurosurgery, National Hospital Organization Disaster Medical Center
  • Hayakawa Takanobu
    Department of Neurosurgery, National Hospital Organization Disaster Medical Center
  • Hirota Shin
    Department of Neurosurgery, Tsuchiura Kyodo General Hospital
  • Yamamoto Shinji
    Department of Neurosurgery, Tsuchiura Kyodo General Hospital
  • Tamada Natsumi
    Department of Neurosurgery, Tokyo‒bay Urayasu‒Ichikawa Medical Center
  • Saigusa Kuniyasu
    Department of Neurosurgery, Tokyo‒bay Urayasu‒Ichikawa Medical Center
  • Maehara Taketoshi
    Department of Neurosurgery, Tokyo Medical and Dental University

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Other Title
  • ワーファリン内服患者における頭蓋内出血に対する人プロトロンビン複合体製剤の使用経験
  • ワーファリン ナイフク カンジャ ニ オケル ズガイ ナイシュッケツ ニ タイスル ヒト プロトロンビン フクゴウタイ セイザイ ノ シヨウ ケイケン

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<p>  Reversal strategies for anti‒coagulants are important in the urgent treatment of intracranial lesions. Four‒factor prothrombin complex concentrates (4F‒ PCC) were approved as a reversal agent for vitamin K antagonist (VKA) in September 2017. This study aims to analyze the efficacy and safety of 4F‒PCC in order to propose its optimal usage in urgent treatments based on our experience. We retrospectively analyzed 18 patients with intracranial hemorrhage associated with head trauma or stroke (7 female patients, 74.1±17.2 years old). Surgical treatment was performed in 11 patients. As concomitant therapy, fresh frozen plasma was used in one patient and vitamin K in 9 patients. The effect of 4F‒PCC was considered by comparing PT‒INR and the volume of hematoma using computed tomography (CT) before and after the administration of 4F‒PCC. The mean value of PT‒INR before administration was 2.94, which decreased to 1.35 following the administration of 4F‒PCC (p<0.001). CT scan revealed no post‒operative hemorrhage in patients who underwent surgical treatment and no increase in the volume of hemorrhage in patients who underwent preservation treatment. No adverse events were observed. Effective and safe reversal of VKA with sufficient hemostasis by the administration of 4F‒PCC was confirmed both in patients who underwent surgical treatment and those who underwent preservation treatment. Although 4F‒PCC is effective in reversing VKA, it remains unclear whether concomitant drugs such as vitamin K or fresh frozen plasma provide a further effect in comparison with the administration of 4F‒PCC alone. Further studies with a greater number of patients and the consideration of concomitant drugs are necessary to fully elucidate the optimal usage of 4F‒PCC.</p>

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