Prothrombinex‐VF use in warfarin reversal and other indications

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.