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

J 2024

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 et. al.

Basic information

Original name

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

Authors

CARAM-DEELDER, Camila, McKinnon Edwards HELLEN, Jarmila A ZDANOWICZ, van den Akker THOMAS, Camilla BIRKEGARD, Jan BLATNÝ (203 Czech Republic, belonging to the institution), 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 and Frederic J MERCIER

Edition

Journal of Clinical Medicine, Basel, MDPI, 2024, 2077-0383

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30204 Oncology

Country of publisher

Switzerland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 3.900 in 2022

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.3390/jcm13092656

UT WoS

001219832000001

Keywords in English

recombinant activated factor VII; post-partum hemorrhage; pregnancy complications; hematologic; coagulants; therapeutic use; thromboembolic events; delivery; obstetric; maternal mortality

Abstract

V originále

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.

Citovat

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 and Frederic J MERCIER. Efficacy and Safety Analyses of Recombinant Factor VIIa in Severe Post-Partum Hemorrhage. Journal of Clinical Medicine. Basel: MDPI, 2024, vol. 13, No 9, p. 1-14, 17 pp. ISSN 2077-0383. Available from: https://dx.doi.org/10.3390/jcm13092656.

@article{2424066,
   author = {CaramandDeelder, Camila and Hellen, McKinnon Edwards and Zdanowicz, Jarmila A and Thomas, van den Akker and Birkegard, Camilla and Blatný, Jan and van der Bom, Johanna G and Colucci, Giuseppe and van Duuren, Derek and van Geloven, Nan and Henriquez, Dacia D C A and Knight, Marian and Korsholm, Lars and Landorph, Andrea and Geraldine, Lavigne Lissalde and McQuilten, Zoe K and Surbek, Daniel and Wellard, Cameron and Wood, Erica M and Mercier, Frederic J},
   article_location = {Basel},
   article_number = {9},
   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},
   language = {eng},
   issn = {2077-0383},
   journal = {Journal of Clinical Medicine},
   title = {Efficacy and Safety Analyses of Recombinant Factor VIIa in Severe Post-Partum Hemorrhage},
   url = {https://www.mdpi.com/2077-0383/13/9/2656},
   volume = {13},
   year = {2024}
}

TY  - JOUR
ID  - 2424066
AU  - 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
PY  - 2024
TI  - Efficacy and Safety Analyses of Recombinant Factor VIIa in Severe Post-Partum Hemorrhage
JF  - Journal of Clinical Medicine
VL  - 13
IS  - 9
SP  - 1-14
EP  - 1-14
PB  - MDPI
SN  - 20770383
KW  - recombinant activated factor VII
KW  - post-partum hemorrhage
KW  - pregnancy complications
KW  - hematologic
KW  - coagulants
KW  - therapeutic use
KW  - thromboembolic events
KW  - delivery
KW  - obstetric
KW  - maternal mortality
UR  - https://www.mdpi.com/2077-0383/13/9/2656
N2  - 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.
ER  -

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 and Frederic J MERCIER. Efficacy and Safety Analyses of Recombinant Factor VIIa in Severe Post-Partum Hemorrhage. \textit{Journal of Clinical Medicine}. Basel: MDPI, 2024, vol.~13, No~9, p.~1-14, 17 pp. ISSN~2077-0383. Available from: https://dx.doi.org/10.3390/jcm13092656.

Detailed Information on Publication Record