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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.


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, n = 20; 4F-PCC, n = 22). 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; P < 0.0001). Median infusion volumes were significantly smaller (103 [80, 130]?mL versus 870 [748, 1001]?mL; P < 0.0001) 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; P = 0.037). 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.

SUBMITTER: Refaai MA 

PROVIDER: S-EPMC5625753 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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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.

Refaai Majed A MA   Kothari Truptesh H TH   Straub Shana S   Falcon Jacob J   Sarode Ravi R   Goldstein Joshua N JN   Brainsky Andres A   Omert Laurel L   Lee Martin L ML   Milling Truman J TJ  

Emergency medicine international 20170919


<h4>Introduction</h4>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.<h4>Methods</h4>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, in  ...[more]

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