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| What about the use of recombinant Factor VIIa in surgery? |
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Recombinant Factor VIIa was evaluated as a hemostatic agent in elective surgery for hemophilia patients with inhibitors. This double-blind, randomized, multicenter study allowed for 5 days of blinded treatment with either of two dose regimens (35 or 90 mg/kg) in either major or minor surgical conditions. Minor surgery included central line placement or removal; whereas, major surgery included all orthopedic procedures as well as one renal biopsy.
Recombinant Factor VIIa was administered by IV bolus prior to surgery, intraoperatively as needed, and then every 2 hours for 48 hours after wound closure. During the first 48 hours, repeat blinded doses of recombinant Factor VIIa were allowed between each 2-hour interval for excessive bleeding. Dosing interval was investigator determined (2 to 6 hours) for the following 3 days. At any time during the study, open-label escape doses of up to 180 micrograms/kg could be given if hemostasis was not obtained. Open-label use was continued after day 5 as necessary. Administration of an escape dose resulted in categorization of the patient as a treatment failure. Efficacy was determined by the investigator using a hemostasis rating scale.
Of 29 patients entered in the study, 23 (one patient discontinued due to adverse event) successfully reached the 5-day study period with satisfactory hemostasis. Nine patients completed the study within the 5-day double-blind treatment period. Five patients (4 low dose, 1 high dose) were considered hemostatic failures and required escape doses.
Major surgery was defined as any orthopedic procedure and minor surgery as venous access catheter placement or removal. When compared, a statistically significant difference in the efficacy was demonstrated across surgical categories in favor of the higher 90 micrograms/kg dose group. The 90 micrograms/kg dose of recombinant Factor VIIa provided a statistically significant increase in hemostasis in both minor and major surgery from day 3 to 5. Although questions about optimal dose remain, the results of this study suggest that elective surgery for patients with bleeding disorders can be undertaken when recombinant Factor VIIa is used as a hemostatic agent.
Shapiro AD et al. Thromb Haemost 1998;80:773-778. |
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