This trial is conducted in North America. The aim of this trial is to compare the safety and efficacy of activated recombinant human factor VII in patients with haemophilia A or B undergoing major surgical procedures.

Inclusion Criteria:

• Have haemophilia A or B with inhibitors to factor VIII or IX, respectively
• Have had a historical inhibitor level of at least five Bethesda units or have had an inadequate haemostatic response to 250 U/kg of factor VIII or IX or have had an inadequate response to FEIBA
• Require pre-planned major surgery in hospital

Exclusion Criteria:

• Have participated in or have been treated with any investigational drug other than activated recombinant human factor VII within the last thirty days
• Have been treated with any haemostatic agent, including rFVIIa, within 48 hours of preoperative dose
• Have any haemostatic disorder other than haemophilia