Efficacy and Safety Analysis of Recombinant Factor VIIa in Severe Post-partum Hemorrhage

How to cite: Caram-Deelder, C.; McKinnon Edwards, H.; Zdanowicz, J.A.; Van den Akker, T.; Birkegård, C.; Blatný, J.; Van der Bom, J.; Colucci, G.; Van Duuren, D.; Van Geloven, N.; Henriquez, D.; Knight, M.; Korsholm, L.; Landorph, A.; Lavigne Lissalde, G.; McQuilten, Z.K.; Surbek, D.; Wellard, C.; Wood, E.M.; Mercier, F.J. Efficacy and Safety Analysis of Recombinant Factor VIIa in Severe Post-partum Hemorrhage. Preprints 2024, 2024030153. https://doi.org/10.20944/preprints202403.0153.v1 Caram-Deelder, C.; McKinnon Edwards, H.; Zdanowicz, J.A.; Van den Akker, T.; Birkegård, C.; Blatný, J.; Van der Bom, J.; Colucci, G.; Van Duuren, D.; Van Geloven, N.; Henriquez, D.; Knight, M.; Korsholm, L.; Landorph, A.; Lavigne Lissalde, G.; McQuilten, Z.K.; Surbek, D.; Wellard, C.; Wood, E.M.; Mercier, F.J. Efficacy and Safety Analysis of Recombinant Factor VIIa in Severe Post-partum Hemorrhage. Preprints 2024, 2024030153. https://doi.org/10.20944/preprints202403.0153.v1

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MDPI and ACS Style

Caram-Deelder, C.; McKinnon Edwards, H.; Zdanowicz, J.A.; Van den Akker, T.; Birkegård, C.; Blatný, J.; Van der Bom, J.; Colucci, G.; Van Duuren, D.; Van Geloven, N.; Henriquez, D.; Knight, M.; Korsholm, L.; Landorph, A.; Lavigne Lissalde, G.; McQuilten, Z.K.; Surbek, D.; Wellard, C.; Wood, E.M.; Mercier, F.J. Efficacy and Safety Analysis of Recombinant Factor VIIa in Severe Post-partum Hemorrhage. Preprints 2024, 2024030153. https://doi.org/10.20944/preprints202403.0153.v1

APA Style

Caram-Deelder, C., McKinnon Edwards, H., Zdanowicz, J.A., Van den Akker, T., Birkegård, C., Blatný, J., Van der Bom, J., Colucci, G., Van Duuren, D., Van Geloven, N., Henriquez, D., Knight, M., Korsholm, L., Landorph, A., Lavigne Lissalde, G., McQuilten, Z.K., Surbek, D., Wellard, C., Wood, E.M., & Mercier, F.J. (2024). Efficacy and Safety Analysis of Recombinant Factor VIIa in Severe Post-partum Hemorrhage. Preprints. https://doi.org/10.20944/preprints202403.0153.v1

Chicago/Turabian Style

Caram-Deelder, C., Erica M Wood and Frederic J Mercier. 2024 "Efficacy and Safety Analysis of Recombinant Factor VIIa in Severe Post-partum Hemorrhage" Preprints. https://doi.org/10.20944/preprints202403.0153.v1

Abstract

Background: Despite a range of available treatments, there is a remaining unmet need for patients with severe post-partum hemorrhage (sPPH). Objective: This manuscript evaluated efficacy and safety of recombinant activated factor VIIa (rFVIIa) in sPPH management. Methods: An open-label, multi-center, randomized controlled trial (RCT; NCT00370877) and four observational studies (OS; OS-1 [NCT04723979], OS-2, OS-3 and OS-4) were analyzed regarding efficacy (need for subsequent invasive procedures, including uterine compression sutures, uterine or iliac artery ligation, arterial embolization or hysterectomy) and safety (incidence of thromboembolic events [TE] and maternal mortality) of rFVIIa for sPPH. The RCT, and OS-1 and OS-2, included a control group of women who did not receive rFVIIa (with propensity score-matching used in OS-1 and OS-2), whereas OS-3 and OS-4 provided descriptive data for rFVIIa exposed women only. Results: A total of 446 women exposed to rFVIIa and 1,717 non-exposed controls were included. In the RCT, fewer rFVIIa exposed women (50% [21/42]) had an invasive procedure versus non-exposed women (91% [38/42]; odds ratio 0.11, 95% confidence interval 0.03–0.35). In OS-1, more rFVIIa exposed women (58% [22/38]) had an invasive procedure versus non-exposed women (35% [13.3/38]; odds ratio 2.46, 95% confidence interval 1.06–5.99). In OS-2, 17% (3/18) of rFVIIa exposed women and 32% (5.6/17.8) of non-exposed women had an invasive procedure (odds ratio 0.33, 95% confidence interval 0.03–1.75). Across all included women, TEs occurred in 1.5% (0.2% arterial and 1.2% venous) of rFVIIa exposed women and 1.6% (0.2% arterial and 1.4% venous) of non-exposed women with available data. Conclusions: The positive treatment effect of rFVIIa in the RCT was not confirmed in the OS. However, the safety analysis did not show any increased incidence of TEs with rFVIIa treatment.

Keywords

Recombinant FVIIa; Postpartum Hemorrhage; Pregnancy Complications, Hematologic; Coagulants, therapeutic use; Thromboembolic events; Delivery, Obstetric; Maternal mortality

Subject

Medicine and Pharmacology, Obstetrics and Gynaecology

Copyright: 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.

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