Impact of recombinant activated factor VII on health-related quality of life after intracerebral hemorrhage

Michael N. Diringer, Jean Marc Ferran, Joseph Broderick, Stephen Davis, Stephan A. Mayer, Thorsten Steiner, Nikolai C. Brun, Brett E. Skolnick, Michael C. Christensen

Research output: Contribution to journalArticlepeer-review

9 Scopus citations

Abstract

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 μg/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.

Original languageEnglish
Pages (from-to)219-225
Number of pages7
JournalCerebrovascular Diseases
Volume24
Issue number2-3
DOIs
StatePublished - Aug 1 2007

Keywords

  • Intracerebral hemorrhage
  • Quality of life
  • Recombinant factor VIIa

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