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4-Factor Prothrombin Concentrate Administration and Its Challenges

      We read with much interest the article, “4-Factor Prothrombin Complex Concentrate Administration via Intraosseous Access for Urgent Reversal of Warfarin” by Peyko et al. in The Journal of Emergency Medicine (
      • Peyko V.
      • Shams D.
      • Urbanski R.
      • Noga J.
      4-Factor prothrombin complex concentrate administration via intraosseous access for urgent reversal of warfarin.
      ). The authors have described functional recovery after intraosseous administration of 4-factor prothrombin complex concentrate (4F-PCC) in a patient with traumatic intraparenchymal hemorrhage with mass effect. While administration of 4F-PCC appears promising in improving morbidity, the clinician needs to be aware of the exclusion criteria that have been used in clinical trials. Pertaining to patients with intracranial hemorrhage, the presence of a Glasgow Coma Scale (GCS) score < 7, intracerebral hematoma volume of > 30 cm3, subdural hematoma with maximum thickness of > 10 mm, midline shift of > 5 mm, subarachnoid hemorrhage with evidence of hydrocephalus, intraventricular extension of hemorrhage, and pre-intracranial hemorrhage (ICH) modified Rankin score of > 3, have been used as exclusion criteria (
      • Sarode R.
      • Milling Jr., T.J.
      • Refaai M.A.
      • et al.
      Efficacy and safety of a 4-factor prothrombin complex concentrate in patients on vitamin K antagonists presenting with major bleeding: a randomized, plasma-controlled, phase IIIb study.
      ). These exclusion criteria intend to exclude patients with a higher risk of morbidity. However, this patient was administered 4F-PCC, despite having a midline shift of 5.7 mm, reiterating the fact that clinical judgment of the treating emergency physician has a significant role in improving outcomes in a particular patient. In the article authors have demonstrated a newer route of administration of 4F-PCC. They have also shown rapid improvement in the patient's international normalized ratio (INR), as defined by INR of < 1.3 within 0.5 h of administration of the above (
      • Peyko V.
      • Shams D.
      • Urbanski R.
      • Noga J.
      4-Factor prothrombin complex concentrate administration via intraosseous access for urgent reversal of warfarin.
      ,
      • Kushimoto S.
      • Fukuoka T.
      • Kimura A.
      • et al.
      Efficacy and safety of a 4-factor prothrombin complex concentrate for rapid vitamin K antagonist reversal in Japanese patients presenting with major bleeding or requiring urgent surgical or invasive procedures: a prospective, open-label, single-arm phase 3b study.
      ).
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      References

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