Neurocritical Care

, Volume 20, Issue 3, pp 466–469

Comparison of a Low, Fixed Dose and a High, Weight-Based Dose of Recombinant Factor VIIa in the Treatment of Warfarin-Associated Intracranial Hemorrhage

  • Adele Robbins
  • Jeffrey Fong
  • Wiley Hall
  • Kristen Ditch
  • Stephen Rolfe
  • Melissa Miller
Original Article

DOI: 10.1007/s12028-013-9841-2

Cite this article as:
Robbins, A., Fong, J., Hall, W. et al. Neurocrit Care (2014) 20: 466. doi:10.1007/s12028-013-9841-2

Abstract

Background

Recombinant activated Factor VII (rFVIIa) can be used for rapid INR normalization in patients with warfarin-associated intracranial hemorrhage (WA-ICH); however, the optimal dose to normalize INR has not been established.

Methods

This is a retrospective review comparing two rFVIIa hospital protocols for WA-ICH [weight-based dose (80 mcg/kg) or fixed dose (2 mg)]. Primary endpoint was the percentage of patients with INR reversal (INR <1.3) at the next INR draw and the need for further doses of rFVIIa. Secondary endpoints included time to documented INR reversal and sustained INR normalization, morbidity, mortality, change in hematoma size, cost, and adverse drug reactions.

Results

Twenty-nine patients were included in each group. The weight-based group received a mean dose of 78.9 ± 21 mcg/kg versus 26.6 ± 8 mcg/kg in the fixed dose group. More patients in the fixed dose protocol achieved documented INR reversal than those in the weight-based group (92.6 vs 72.4 %, p = 0.19). The weight-based group achieved INR normalization in 229.5 [102, 331] minutes versus 165 [83, 447] minutes in the fixed dose group (p=0.02). Time to sustained INR normalization was similar in both groups. Four patients in the fixed dose group received an additional dose of 1 mg per hospital protocol. With the exception of medication acquisition cost savings of about $4,300 per patient who received fixed dose protocol, all other endpoints were similar between groups.

Conclusions

A low, fixed dose of rFVIIa appears to be as effective as a high, weight-based dose in achieving INR normalization in patients with WA-ICH.

Keywords

Recombinant factor VIIaIntracranial hemorrhageWarfarin

Copyright information

© Springer Science+Business Media New York 2013

Authors and Affiliations

  • Adele Robbins
    • 1
  • Jeffrey Fong
    • 2
    • 3
  • Wiley Hall
    • 2
  • Kristen Ditch
    • 2
  • Stephen Rolfe
    • 4
  • Melissa Miller
    • 2
  1. 1.Department of PharmacyWake Forest University Baptist Medical CenterWinston SalemUSA
  2. 2.UMass Memorial Medical CenterWorcesterUSA
  3. 3.Massachusetts College of Pharmacy and Health SciencesWorcesterUSA
  4. 4.University of New England, College of PharmacyPortlandUSA