Haemostatic efficacy and safety of bolus and continuous infusion of recombinant factor VIIa are comparable in XXXX @entity1 with inhibitors undergoing major surgery. Results from an open-label, randomized, multicenter trial.

@entity1 @entity2801 @entity548 @entity447 @entity4682
Bolus infusion (BI) recombinant factor VIIa (rFVIIa) administration is safe and effective in the surgical management of @entity447 @entity1 with inhibitors but has not been compared directly with continuous infusion (CI). We conducted an open-label, randomized, multicenter trial comparing the efficacy and safety of rFVIIa administered by BI or CI for the surgical management of @entity447 or B @entity1 with inhibitors to @entity2801 or @entity4682 . Safety was compared with that of a control group of non-inhibitor @entity1 receiving @entity2801 or @entity4682 concentrates for major surgery. All inhibitor subjects received an initial bolus dose of 90 microg/kg rFVIIa and were then randomly assigned to BI (n = 12) or CI (n = 12). The BI group received 90 microg/kg rFVIIa every two hours (h) during surgery through day 5, then every four hours for days 6-10. The CI group received 50 microg/kg/h rFVIIa through day 5, then 25 mg/kg/h for days 6-10. The control group (n = 12) received @entity2801 or @entity4682 per institutional protocols. Twenty-two major surgeries included orthopedic procedures on the knee (n = 13), hip (n = 3), and abdominal/pelvis procedures (n = 4). One @entity1 with an autoimmune @entity2801 inhibitor randomized to the BI arm was excluded from efficacy analysis. Haemostatic efficacy of rFVIIa in each group was comparable: effective in 8/11 and 9/12 subjects in the BI and CI arms, respectively, and ineffective in three subjects in each arm. Serious adverse events were related to continued or increased @entity548 . In conclusion, haemostatic efficacy and safety of BI and CI of rFVIIa are comparable for the surgical management of @entity447 subjects with inhibitors.
