The use of recombinant activated factor VII in trauma patients: Experience from the Australian and New Zealand haemostasis registry.
BACKGROUND
There is increasing use of rFVIIa (eptagog alpha, Novoseven) in injured patients with critical bleeding. The role of rFVIIa is not defined in this group of patients. Registries provide an opportunity to review the patients, reported response and adverse events for rFVIIa.


OBJECTIVE
To determine the pattern of use, reported response and adverse events in patients receiving rFVIIa following injury using the Australian and New Zealand Haemostasis Registry (ANZHR).


METHODS
The ANZHR (commenced May 2005) collects data from 53 hospitals on all patients receiving rFVIIa in those hospitals.


RESULTS
Of 695 cases in the registry, 108 patients from 19 hospitals were submitted with a primary trauma diagnosis. Most (88) patients received one 90microg/kg dose of rFVIIa. There was a significant reduction in the use of all blood products following rFVIIa (p<0.001) and rFVIIa was thought to have decreased or stopped bleeding in 59% of cases. There was wide variation in the timing of rFVIIa use. There were two adverse events that were considered possibly linked and a total of three thromboembolic events. Following multivariate analysis, pH provided the best model of response to rFVIIa. Patients with a pH<7.05 were significantly less likely to respond (OR=0.3, 95% CI=0.0-0.3). Only two patients would fit the criteria for the present prospective study of rFVIIA in trauma patients.


CONCLUSIONS
The best approach to managing critical bleeding in trauma patients is not agreed. The role of rFVIIa will only be clarified if there is a standardised approach to fluid management and transfusion of blood products. The registry allows tracking of current practice, outcomes and adverse events and will complement present phase 2 and 3 trials.
Cameron
Peter
P
Department of Epidemiology and Preventive Medicine, Monash University and Alfred Hospital Emergency and Trauma Centre, Melbourne, Australia. peter.cameron@med.monash.edu.au
Phillips
Louise
L
Balogh
Zsolt
Z
Joseph
Anthony
A
Pearce
Andrew
A
Parr
Michael
M
Jankelowitz
Gary
G
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D001315:Australia; D001777:Blood Coagulation / Q000187:drug effects*; D015942:Factor VIIa / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006470:Hemorrhage / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009104:Multiple Trauma / Q000150:complications / Q000188:drug therapy*; D009520:New Zealand; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012042:Registries / Q000706:statistics & numerical data; D016896:Treatment Outcome
D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa