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Emergency Medicine International
Volume 2017, Article ID 8024356, 8 pages
https://doi.org/10.1155/2017/8024356
Research Article

Four-Factor Prothrombin Complex Concentrate Reduces Time to Procedure in Vitamin K Antagonist-Treated Patients Experiencing Gastrointestinal Bleeding: A Post Hoc Analysis of Two Randomized Controlled Trials

1University of Rochester Medical Center, Rochester, NY, USA
2Seton Dell Medical School Stroke Institute, Dell Children’s Medical Center, University Medical Center at Brackenridge, Austin, TX, USA
3University of Texas Southwestern Medical Center, Dallas, TX, USA
4Massachusetts General Hospital, Boston, MA, USA
5CSL Behring, King of Prussia, PA, USA
6UCLA Fielding School of Public Health, Los Angeles, CA, USA

Correspondence should be addressed to Majed A. Refaai; ude.retsehcor.cmru@iaafer_dejam

Received 4 May 2017; Accepted 6 August 2017; Published 19 September 2017

Academic Editor: Marco L. A. Sivilotti

Copyright © 2017 Majed A. Refaai et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Introduction. To investigate the impact of a 4-factor prothrombin complex concentrate (4F-PCC [Beriplex®/Kcentra®]) versus plasma on “time to procedure” in patients with acute/severe gastrointestinal bleeding requiring rapid vitamin K antagonist (VKA) reversal prior to invasive procedure. Methods. A post hoc analysis of two phase III trials of 4F-PCC versus plasma in patients with acute/severe gastrointestinal bleeding. The treatment arms were compared for study treatment volume, infusion times, and time from start of study treatment to procedure. Results. Analysis included 42 patients (plasma, ; 4F-PCC, ). Median (interquartile range) infusion time was significantly shorter for the 4F-PCC group than for the plasma group (16 [13, 26] min versus 210 [149, 393] min; ). Median infusion volumes were significantly smaller (103 [80, 130] mL versus 870 [748, 1001] mL; ) and median time from study treatment initiation to first procedure was significantly shorter in the 4F-PCC group than in the plasma group (17.5 [12.8, 22.8] versus 23.9 [18.5, 62.0] h; ). Conclusions. In this analysis of patients with acute/severe gastrointestinal bleeding requiring urgent VKA reversal prior to an invasive procedure, 4F-PCC (compared with plasma) was associated with smaller infusion volumes, shorter infusion times, and reduced time to procedure.