Original Primary Outcome:

• Assessment of hemostatic efficacy at the end of surgery
• as determined by the investigator and/or the surgeon using the 4 point ordinal scale

Current Secondary Outcome: Number of Patients Who Achieved Hemostatic Efficacy at Hospital Discharge [ Time Frame: 6 weeks ]

Original Secondary Outcome:

• Efficacy endpoints:
• · Assessment of hemostatic efficacy by the investigator at the day of
• discharge from the hospital;
• · Capture Total Consumption of ReFacto AF and Consumption per bleeding
• event;
• · Capture the number of bleeding episodes and response to treatment;
• · Assess the pharmacokinetics of ReFacto AF in the patient population;
• · Assess the incidence of less than expected therapeutic effect;
• · Comparison of the predicted and actual estimated blood loss and
• transfusion requirements;
• · Monitor the types of continuous infusion regimens and comparison of
• planned regimens versus regimens actually used;
• · Assess patient compliance with prescribed outpatient;
• Safety endpoints:
• · Adverse events;
• · Incidence of Factor VIII inhibitor development, thrombosis and
• allergic reactions in the patient population

Dates:
Date Received: October 20, 2005
Date Started: April 2006
Date Completion:
Last Updated: June 2, 2011
Last Verified: June 2011