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Comparison of outcomes for fixed and weight-based four-factor prothrombin complex concentrate dosing regimens.

Amal Bittar1, Carl Zipperlen2, Gregory Gilbert3

  • 1Pharmacy, Mount Sinai South Nassau, Oceanside, New York, USA amalbittar10@gmail.com.

European Journal of Hospital Pharmacy : Science and Practice
|September 19, 2023
PubMed
Summary

Fixed dose four-factor prothrombin complex concentrate (4F-PCC) offers comparable hemostasis to weight-based dosing. Fixed regimens also provide faster administration times without impacting mortality rates in bleeding patients.

Keywords:
AnticoagulantsCLINICAL MEDICINECRITICAL CAREEvidence-Based MedicineStroke

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Area of Science:

  • Hematology
  • Pharmacology
  • Clinical Medicine

Background:

  • Fixed dose regimens for four-factor prothrombin complex concentrate (4F-PCC) are increasingly used, but their efficacy compared to weight-based dosing requires further investigation.
  • Uncertainty exists regarding the 'one size fits all' approach in 4F-PCC administration for various bleeding types and anticoagulants.

Purpose of the Study:

  • To compare hemostasis achievement between fixed dose and weight-based dose 4F-PCC regimens.
  • To evaluate differences in time to administration and in-hospital mortality between the two dosing strategies.

Main Methods:

  • Retrospective cohort study including adult patients receiving 4F-PCC for major bleeding on warfarin or factor-Xa inhibitors.
  • Comparison of fixed dose (treatment) versus weight-based dose (comparator) 4F-PCC regimens.
  • Exclusion criteria included non-urgent procedures, unknown hemorrhage source, non-anticoagulated patients, hepatic failure, dabigatran use, or heparin allergy.

Main Results:

  • No statistically significant difference in hemostasis achievement between fixed dose (45%) and weight-based dose (46%) groups (p=0.872).
  • Fixed dose 4F-PCC administration was significantly faster (32 min vs 46 min, p=0.031).
  • In-hospital mortality rates were similar between groups (29% vs 29%, p=0.968).

Conclusions:

  • Fixed dose 4F-PCC regimens demonstrate comparable hemostasis outcomes to weight-based regimens.
  • Fixed dosing facilitates a quicker administration time, a crucial factor in managing major bleeding events.