Publication details

Efficacy and Safety Analyses of Recombinant Factor VIIa in Severe Post-Partum Hemorrhage

Authors	CARAM-DEELDER Camila HELLEN McKinnon Edwards ZDANOWICZ Jarmila A THOMAS van den Akker BIRKEGARD Camilla BLATNÝ Jan VAN DER BOM Johanna G COLUCCI Giuseppe VAN DUUREN Derek VAN GELOVEN Nan HENRIQUEZ Dacia D C A KNIGHT Marian KORSHOLM Lars LANDORPH Andrea GERALDINE Lavigne Lissalde MCQUILTEN Zoe K SURBEK Daniel WELLARD Cameron WOOD Erica M MERCIER Frederic J
Year of publication	2024
Type	Article in Periodical
Magazine / Source	Journal of Clinical Medicine
MU Faculty or unit	Faculty of Medicine
Citation
Web	https://www.mdpi.com/2077-0383/13/9/2656
Doi	http://dx.doi.org/10.3390/jcm13092656
Keywords	recombinant activated factor VII; post-partum hemorrhage; pregnancy complications; hematologic; coagulants; therapeutic use; thromboembolic events; delivery; obstetric; maternal mortality
Description	Background: Despite a range of available treatments, it is still sometimes challenging to treat patients with severe post-partum hemorrhage (sPPH). Objective: This study evaluated the 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 ligations, 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 1717 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 on the RCT was not confirmed in the OS. However, the safety analysis did not show any increased incidence of TEs with rFVIIa treatment.