The Australian and New Zealand Haemostasis Registry: ten years of data on off-licence use of recombinant activated factor VII

Background. Recombinant activated factor VII (rFVIIa) has been widely used as an off-licence pan-haemostatic agent in patients with critical bleeding. However, outside the trauma setting, there is relatively little high quality evidence on the risks and benefits of this agent. The Haemostasis Registry was established to investigate the extent of use, dosing, safety and outcomes of patients after off-licence rFVIIa treatment of critical bleeding. Materials and methods. The Registry recruited non-haemophiliac patients treated with rFVIIa from 2000-2009 (inclusive) in Australia and New Zealand. Detailed information was gathered on patients demographics, context of bleeding, rFVIIa administration, laboratory results, blood component and other therapies, and outcomes. Outcome measures included subjectively assessed effect of rFVIIa on bleeding (response), adverse events (thromboembolic and other) and 28-day mortality. Results. The registry included 3,446 cases in 3,322 patients (median [IQR] age 56 [33-70] years, 65 (n=2,147) male). Clinical indications included cardiac surgery (45 ), other surgery (18 ), trauma (13 ), medical bleeding (6 ), liver disease (6 ), and obstetric haemorrhage (5 ). The median [IQR] dose was 91 [72-103] ?g/kg and 77 received a single dose. Reduction or cessation of bleeding was reported in 74 and 28-day survival was 71 but outcomes varied depending on clinical context. pH strongly correlated with outcome measures; 81 of patients with pH