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

CARAM-DEELDER, Camila, McKinnon Edwards HELLEN, Jarmila A ZDANOWICZ, van den Akker THOMAS, Camilla BIRKEGARD, Jan BLATNÝ, Johanna G VAN DER BOM, Giuseppe COLUCCI, Derek VAN DUUREN, Nan VAN GELOVEN, Dacia D C A HENRIQUEZ, Marian KNIGHT, Lars KORSHOLM, Andrea LANDORPH, Lavigne Lissalde GERALDINE, Zoe K MCQUILTEN, Daniel SURBEK, Cameron WELLARD, Erica M WOOD a Frederic J MERCIER. Efficacy and Safety Analyses of Recombinant Factor VIIa in Severe Post-Partum Hemorrhage. Journal of Clinical Medicine. Basel: MDPI, 2024, roč. 13, č. 9, s. 1-14, 17 s. ISSN 2077-0383. Dostupné z: https://dx.doi.org/10.3390/jcm13092656.

Základní údaje

• Originální název: Efficacy and Safety Analyses of Recombinant Factor VIIa in Severe Post-Partum Hemorrhage
• Autoři: CARAM-DEELDER, Camila, McKinnon Edwards HELLEN, Jarmila A ZDANOWICZ, van den Akker THOMAS, Camilla BIRKEGARD, Jan BLATNÝ (203 Česká republika, domácí), Johanna G VAN DER BOM, Giuseppe COLUCCI, Derek VAN DUUREN, Nan VAN GELOVEN, Dacia D C A HENRIQUEZ, Marian KNIGHT, Lars KORSHOLM, Andrea LANDORPH, Lavigne Lissalde GERALDINE, Zoe K MCQUILTEN, Daniel SURBEK, Cameron WELLARD, Erica M WOOD a Frederic J MERCIER.
• Vydání: Journal of Clinical Medicine, Basel, MDPI, 2024, 2077-0383.

Další údaje

• Originální jazyk: angličtina
• Typ výsledku: Článek v odborném periodiku
• Obor: 30204 Oncology
• Stát vydavatele: Švýcarsko
• Utajení: není předmětem státního či obchodního tajemství
• WWW: URL
• Impakt faktor: Impact factor: 3.900 v roce 2022
• Organizační jednotka: Lékařská fakulta
• Doi: http://dx.doi.org/10.3390/jcm13092656
• UT WoS: 001219832000001
• Klíčová slova anglicky: recombinant activated factor VII; post-partum hemorrhage; pregnancy complications; hematologic; coagulants; therapeutic use; thromboembolic events; delivery; obstetric; maternal mortality
• Štítky: 14110321, rivok
• Příznaky: Mezinárodní význam, Recenzováno

Anotace

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.