Use of rFVIIa for critical bleeding in cardiac surgery: dose variation and patient outcomes.
OBJECTIVE
Recombinant activated factor VIIa (rFVIIa) is increasingly being used in non-haemophiliac patients for the treatment of severe bleeding refractory to standard interventions. Optimal dosing regimens remain debated in cardiac surgery. Therefore, this study investigated the use of different rFVIIa dosing practices on response to bleeding and patient outcomes in cardiac surgery patients using data from the Haemostasis Registry.


METHODS
Data were extracted from the Haemostasis Registry that records cases of off-licence rFVIIa use in participating institutions. Univariate analyses compared patients receiving < or =40 microg/kg, 41-60 microg/kg, 61-80 microg/kg, 81-100 microg/kg and >100 microg/kg of rFVIIa on key parameters. Logistic regression models investigated the relationship between independent variables and 28-day mortality.


RESULTS
Complete data was available on 804 cardiac surgery patients who received rFVIIa. Of these, 42 (5.2%) were treated with doses < or =40 microg/kg, while the dose group containing the most patients was 81-100 microg/kg (368, 45.77%). Results demonstrated no significant differences in the rate of thromboembolic adverse events, response to bleeding or 28-day mortality.


CONCLUSIONS
These findings raise the important question of whether lower doses of rFVIIa may be as effective as higher doses in the treatment of severe bleeding in cardiac surgery patients.
Willis
C
C
Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.
Bird
R
R
Mullany
D
D
Cameron
P
P
Phillips
L
L
D000368:Aged; D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D015942:Factor VIIa / Q000008:administration & dosage*; D005260:Female; D006470:Hemorrhage / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000188:drug therapy* / Q000209:etiology; D011994:Recombinant Proteins / Q000008:administration & dosage; D016896:Treatment Outcome
D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa