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Prothrombinex-VF use in warfarin reversal and other indications.
Medical Journal of Australia 2012 April 17
OBJECTIVE: To assess the use of Prothrombinex-VF powder for injection (PTX-VF) at Royal Perth Hospital and analyse the efficacy and safety profile of PTX-VF.
DESIGN, SETTING AND PATIENTS: A prospective observational audit of PTX-VF use, conducted by reviewing medical records and laboratory and imaging results for all patients prescribed PTX-VF from 1 November 2009 to 1 May 2010.
MAIN OUTCOME MEASURES: Data on indication, diagnosis, comorbidities, dose of PTX-VF, fresh frozen plasma (FFP) and vitamin K, coagulation parameters before and after PTX-VF administration, and adverse effects.
RESULTS: 334 vials of PTX-VF were administered to 84 patients over 107 prescriptions. Indications were warfarin reversal, intraoperative bleeding and coagulopathy (66, 20 and 21 prescriptions, respectively). PTX-VF with FFP was compared with PTX-VF alone for warfarin reversal and there was a significant decrease in international normalised ratio (INR) that was independent of group (P < 0.001). Lower doses of PTX-VF (< 25 IU/kg) were compared with higher doses (25-50 IU/kg) for warfarin reversal and decrease in INR was significant, independent of group (P = 0.002). PTX-VF was administered for intraoperative bleeding in 18 patients who had not been treated with warfarin. No hypersensitivity reactions, thrombotic complications or worsening of disseminated intravascular coagulation occurred during 7-day follow-up.
CONCLUSION: For warfarin reversal, lower doses of PTX-VF (< 25 IU/kg) and PTX-VF without FFP were effective. PTX-VF was also used in intraoperative bleeding and non-warfarin coagulopathy. No adverse events were associated with PTX-VF.
DESIGN, SETTING AND PATIENTS: A prospective observational audit of PTX-VF use, conducted by reviewing medical records and laboratory and imaging results for all patients prescribed PTX-VF from 1 November 2009 to 1 May 2010.
MAIN OUTCOME MEASURES: Data on indication, diagnosis, comorbidities, dose of PTX-VF, fresh frozen plasma (FFP) and vitamin K, coagulation parameters before and after PTX-VF administration, and adverse effects.
RESULTS: 334 vials of PTX-VF were administered to 84 patients over 107 prescriptions. Indications were warfarin reversal, intraoperative bleeding and coagulopathy (66, 20 and 21 prescriptions, respectively). PTX-VF with FFP was compared with PTX-VF alone for warfarin reversal and there was a significant decrease in international normalised ratio (INR) that was independent of group (P < 0.001). Lower doses of PTX-VF (< 25 IU/kg) were compared with higher doses (25-50 IU/kg) for warfarin reversal and decrease in INR was significant, independent of group (P = 0.002). PTX-VF was administered for intraoperative bleeding in 18 patients who had not been treated with warfarin. No hypersensitivity reactions, thrombotic complications or worsening of disseminated intravascular coagulation occurred during 7-day follow-up.
CONCLUSION: For warfarin reversal, lower doses of PTX-VF (< 25 IU/kg) and PTX-VF without FFP were effective. PTX-VF was also used in intraoperative bleeding and non-warfarin coagulopathy. No adverse events were associated with PTX-VF.
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