A retrospective evaluation of the use of B-domain deleted recombinant Factor VIII (ReFacto®) administered by continuous infusion during surgical procedures

Abstract number: P1641

Schulman^* S., Roussel-Robert† V., Stieltjes† N., Negrier‡ C., Reynaud§ J., Villar¶ A., Pouzol†† P., Savidge^** G. F., Altisent‡‡ C., Auerswald§§ G.

†Hôpital Cochin, France; ‡Hôpital E Herriot, France; §Hôpital Nordf, France; ††Hôpital Robert Debre, France; ¶Hospital de la Paz, Spain; ‡‡Hospital Vall d'Hebron, Spain; ^*Karolinska Hospital, Sweden; ^**St Thomas' Hospital, UK; §§Zentralkrankenhaus, Germany

Delivery of FVIII by continuous infusion (CI) maintains plasma concentrations constantly above the minimum levels needed for effective hemostasis. Compared with bolus delivery, it provides improved safety and reduces FVIII consumption. This retrospective multicenter study evaluated the efficacy and safety of B-domain deleted recombinant FVIII (ReFacto®, moroctocog alfa) administered by CI during surgical procedures in patients with hemophilia A. Fifteen patients aged 4–66 years who received >=5 consecutive days of treatment with ReFacto during 19 surgical procedures (16/19 in patients with severe hemophilia A and 15/19 orthopedic) were evaluated. All patients had previously received FVIII or other blood products. One patient had a history of FVIII inhibitors, although his preoperative inhibitor status was negative. Baseline virology was positive for HIV or hepatitis A, B or C in 8/19, 9/19, 15/19 and 15/19 procedures, respectively. During the 19 procedures, patients received a preoperative bolus dose of ReFacto (median 53 IU kg^-1[23–79 IU kg^-1]) followed by CI ReFacto 10 000–173 160 IU over 5–35 days. Continuous infusion was administered using a minipump (16 procedures) or syringe pump (3 procedures) via a peripheral (14 procedures) or central (5 procedures) venous catheter. Additional bolus ReFacto was administered in 11 procedures and blood products in 8 procedures. Surgeons rated as ‘easy’ or ‘very easy’ both (1) the preparation of ReFacto for CI in 17 procedures and (2) its ease of handling during infusion in 16 procedures. They assessed the hemostatic outcome as ‘excellent’ or ‘good’ in 14 procedures. Sixteen nonserious adverse events (11/16 nondrug related) were reported in 7 patients. Two patients experienced a total of 4 serious adverse events (bleeding or postoperative anemia), which were possibly treatment related. There were no reports of inhibitor development. Compared to their previous experience with FVIII bolus dosing, surgeons rated the efficacy of ReFacto CI to be comparable or superior in 14 procedures (no data: 5 procedures), with less or comparable consumption of ReFacto in 14 procedures (no data: 4 procedures), and lower or comparable treatment costs in 14 procedures (no data: 5 procedures). These data suggest that CI of ReFacto appears to be effective and convenient to use during surgical procedures in patients with hemophilia A.

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