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• W2318251159 abstract "Introduction: Excessive bleeding, especially in the perioperative period, remains a major complication following surgery. This potential refractory hemorrhage is a major contributor to morbidity and mortality in a variety of patient populations. Recombinant factor VIIa is a prothrombotic agent that binds to tissue factor when exposed to circulating blood following tissue injury. Currently rFVIIa has FDA approval for hemophilia A or B with inhibitors to Factor VIII or Factor IX, but has been commonly used for many off-label indications. The current FDA approved dose for patients with hemophilia is 90 micrograms per kg (mcg/kg) to be given every 2 hours until hemostasis is reached. However, rFVIIa dosing ranges from 10 to 400 mcg/kg have been reported in the literature all depending on hematologist preference, or clinical experience. The high potential for harm to the patient and uncertainty within the published literature regarding appropriate dosing strategy led to the development of a specific dosing protocol at our institution. This study reports our experience and outcome data with a novel low dose, and sequential dosing treatment scheme using rFVIIa at an academic medical center. Methods: Retrospective cohort, non-inferiority study of one hundred ninety-seven patients treated with a multidisciplinary protocol for off-label recombinant factor VII for coagulopathy reversal or treatment refractory critical bleeding. Adult patients were excluded from the analysis if there was insufficient data in the medical record or if administration was for an on-label indication. The primary endpoint was all cause mortality in the pre-protocol population when compared to the post protocol population. Secondary endpoints included difference in average dose of recombinant factor VII administered, hospital length of stay, blood product utilization, and adverse effects from recombinant factor VII administration. Results: No differences were identified in the populations of patients treated prior to the implementation of the activated recombinant factor VII (rFVIIa) protocol to those afterwards except for increased home anticoagulant use in the post protocol population. All-cause mortality remained consistent between the post and pre groups respectively (35% vs. 48.8%, p=0.057). Patients receiving recombinant factor VII after the protocol was implemented received a smaller average dose as compared to those patients treated prior to the new protocol (47.5 mcg/kg vs. 62.2 mcg/kg, p=0.036). This difference of almost 15 mcg/kg, translates to a dose reduction of around 1250 mcg rFVIIa (average weight of 85 kg of patients in study). Assuming 1 mg of rFVIIa cost around $1500, then based on the average reduction in dose one could expect an average cost savings of almost $1900 per patient. The rate of combined thromboembolic events was similar between the post and pre protocol population (0.06% vs. 0.05%, p=0.77). Significantly less total blood products were utilized in the post protocol population when compared to the pre protocol (32.3 vs. 45.7, p=0.06). The average observed hospital length of stay was not significantly different between the groups (23.7 days vs. 19.6 days, p= 0.199). Conclusions: The implementation of a multidisciplinary protocol for recombinant factor VII provided a significantly lower average dose while not sacrificing for patient mortality, thromboembolic events, or blood product administration. A larger study should be considered to confirm the results of this single center study." @default.
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• W2318251159 date "2013-12-01" @default.
• W2318251159 modified "2023-09-28" @default.
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• W2318251159 doi "https://doi.org/10.1097/01.ccm.0000439462.87589.c5" @default.
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