Recombinant activated factor VII in critical bleeding: experience from the Australian and New Zealand Haemostasis Register

Abstract

Background: There has been increasing off‐label use of recombinant activated factor VII (rFVIIa/NovoSeven; Novo Nordisk, Bagsvaerd, Denmark) for patients with critical bleeding. Given the lack of high‐level evidence, the clinical indications, observed response and adverse events are important to capture. Methods: The Haemostasis Registry collects retrospective and contemporaneous data on all use of rFVIIa at participating institutions for non‐haemophiliac patients with critical bleeding (i.e. off‐label use). Results: As of October 2006, 694 cases had been reported into the register from 37 hospitals across Australia and New Zealand. These comprise an array of therapeutic categories, including salvage use in: perioperative cardiothoracic surgery (44%), trauma (16%), medical bleeding (9%), obstetric bleeding (4%) and other types of critical bleeding (28%). Patients received a median (interquartile range) dose of 91 μg/kg (75–103) and 83% of patients received a single dose of rFVIIa. The documented response rate to a single dose of rFVIIa was 69%. The 28‐day survival was 68%, but varied with clinical category. The rate of adverse events probably or possibly linked to the use of rFVIIa was 6%, with most of the thromboembolic adverse events occurring in the cardiac surgery group. Conclusion: The Haemostasis Registry cannot replace well‐designed prospective randomized controlled trials, but in their absence this registry provides a basis for understanding current clinical experience of rFVIIa. Registries continue to be vital in monitoring off‐label uses of medications.