Impact of recombinant activated factor VII on health-related quality of life after intracerebral hemorrhage.
BACKGROUND
We recently demonstrated that recombinant activated factor VII (rFVIIa) given to patients presenting within 3 h of acute spontaneous intracerebral hemorrhage (ICH) reduces mortality (18% vs. 29%) and poor outcome (modified Rankin Scale, mRS, 4-6, 53 vs. 69%). This analysis was performed to determine the impact of rFVIIa on health-related quality of life (HRQoL) in those patients.


METHODS
In a prospective, randomized controlled trial, 399 patients (mean age, 66 years) received placebo, 40, 80 or 160 microg/kg of rFVIIa within 4 h of acute ICH. At 90 days, HRQoL was assessed with the EuroQoL (EQ-5D), a 5-dimensional measure of health which also includes the Visual Analogue Scale. Additionally, each level of the 90-day mRS was adjusted, using 4 different previously published utility values, to obtain a clearer picture of perceived HRQoL.


RESULTS
Among the 5 dimensions of EQ-5D, only mobility rating was significantly better for rFVIIa-treated patients (serious problems, 34 vs. 54%; p = 0.01). Yet, the utility value (scaled 1.0 = perfect health and 0.0 = dead) associated with the composite EQ-5D demonstrated significantly better HRQoL (0.48 vs. 0.36; p = 0.01). This was also true for the EQ-5D Visual Analogue Scale score (44 vs. 36; p = 0.04). Finally, all 4 algorithms for applying utility scores to the mRS indicated that rFVIIa was associated with significantly better perceived HRQoL (all p < 0.006).


CONCLUSIONS
Treatment with rFVIIa within 4 h of acute spontaneous ICH improves HRQoL.
Diringer
Michael N
MN
Department of Neurology, Washington University School of Medicine, St. Louis, MO 63110, USA. diringerm@neuro.wustl.edu
Ferran
Jean-Marc
JM
Broderick
Joseph
J
Davis
Stephen
S
Mayer
Stephan A
SA
Steiner
Thorsten
T
Brun
Nikolai C
NC
Skolnick
Brett E
BE
Christensen
Michael C
MC
D000208:Acute Disease; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D001208:Asia; D001315:Australia; D002543:Cerebral Hemorrhage / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D003029:Coagulants / Q000008:administration & dosage / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005060:Europe; D015942:Factor VIIa / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D010465:Perception; D011446:Prospective Studies; D011788:Quality of Life; D011994:Recombinant Proteins / Q000627:therapeutic use; D020127:Recovery of Function; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014481:United States
D003029:Coagulants; D011994:Recombinant Proteins; D015942:Factor VIIa