Abstract
Introduction:
The role of Recombinant activated factor VII (rFVIIa, NovoSeven) for off-label indications, including trauma, cardiac surgery and other critical bleeding episodes, remains controversial. Through the Haemostasis Registry, we report on the Australian and New Zealand experience of using rFVIIa.
Methods:
Monash University has established the Haemostasis Registry (with an educational grant from NovoNordisk Pharmaceuticals) to monitor the use of rFVIIa throughout Australia and New Zealand. More than 50 hospitals are contributing data to the Registry.
Results:
Over 600 cases have been reported to the Register. In those where complete data has been received, major areas of use are cardiac surgery (~42%), other surgery (~19%) and trauma (~13%). The reported efficacy of rFVIIa was high (where reported, in >70% cases bleeding decreased or stopped after first dose of rFVIIa) while the reported Adverse Events “possibly” or “probably” linked to rFVIIa use were relatively low (~6%). There were no directly linked adverse events. Despite suffering from conditions where mortality is high, the survival rate in rFVIIa recipients was 69% at 28 days post treatment. These results will be compared with international experience and published trials.
Conclusions:
Although randomized controlled trials are important in establishing the safety and efficacy of new treatments, they do not replace the need for registries, especially for treatments where clinicians believe that withholding treatment may be unethical because of potential life threatening consequences. This problem is made more difficult where there are a wide range of applications. As more data becomes available, the Haemostasis Registry data will help to elucidate the safety and efficacy of rFVIIa and provide important feedback to doctors and hospitals.
Letter by Al-Ruzzeh and Navia Regarding Article, “Safety and Efficacy of Recombinant Activated Factor VII: A Randomized Placebo-Controlled Trial in the Setting of Bleeding After Cardiac Surgery”
