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Related Experiment Videos

Anne Juul Wikkelsø1, Jakob Stensballe2,3,4

  • 1Bedøvelse, Operation og Intensiv (Anæstesiologi), Sjællands Universitetshospital, Roskilde.

Ugeskrift for Laeger
|November 25, 2022
PubMed
Summary

Recombinant factor VIIa (rFVIIa) is approved for severe postpartum hemorrhage, but evidence is limited. Its use may reduce secondary treatments but increases thromboembolism risk, warranting cautious application.

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Area of Science:

  • Obstetrics and Gynecology
  • Hematology
  • Pharmacology

Context:

  • Recombinant factor VIIa (rFVIIa) received European approval in April 2022 for severe postpartum hemorrhage (PPH).
  • The approval is based on a small, open-label trial (84 women, 2015) with methodological limitations.
  • Current guidelines recommend rFVIIa as a last resort for life-threatening PPH.

Purpose:

  • To evaluate the efficacy and safety of rFVIIa in treating severe postpartum hemorrhage.
  • To assess the evidence base supporting the extended approval of rFVIIa for PPH.

Summary:

  • The trial showed reduced need for second-line treatments with rFVIIa but indicated an increased risk of thromboembolism.
  • Systematic use of tranexamic acid and advanced coagulation monitoring (thromboelastography/rotational thromboelastometry) were not employed in the study.

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  • Danish and international societies advocate for reserving rFVIIa for the most severe, life-threatening PPH cases.

    • Impact:

    • Highlights the need for robust clinical trials to validate rFVIIa's role in PPH management.
    • Underscores the importance of risk-benefit assessment, particularly regarding thromboembolic events.
    • Informs clinical practice and guideline development for PPH treatment strategies.