Rationale for the Potential Use of Recombinant Activated Factor
VII in Severe Post-Partum Hemorrhage

ACS, Nandor, Wolfgang C KORTE, Christian C VON HEYMANN, Jerzy WINDYGA and Jan BLATNÝ. Rationale for the Potential Use of Recombinant Activated Factor VII in Severe Post-Partum Hemorrhage. Journal of Clinical Medicine. Basel: MDPI, 2024, vol. 13, No 10, p. 1-8. ISSN 2077-0383. Available from: https://dx.doi.org/10.3390/jcm13102928.

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TY  - JOUR
ID  - 2424063
AU  - Acs, Nandor - Korte, Wolfgang C - von Heymann, Christian C - Windyga, Jerzy - Blatný, Jan
PY  - 2024
TI  - Rationale for the Potential Use of Recombinant Activated Factor VII in Severe Post-Partum Hemorrhage
JF  - Journal of Clinical Medicine
VL  - 13
IS  - 10
SP  - 1-8
EP  - 1-8
PB  - MDPI
SN  - 20770383
KW  - massive post-partum hemorrhage
KW  - Novo Seven
KW  - obstetric hemorrhage
KW  - rFVIIa mode of action
UR  - https://www.mdpi.com/2077-0383/13/10/2928
N2  - Severe post-partum hemorrhage (PPH) is a major cause of maternal mortality worldwide. Recombinant activated factor VII (rFVIIa) has recently been approved by the European Medicines Agency for the treatment of severe PPH if uterotonics fail to achieve hemostasis. Although large randomized controlled trials are lacking, accumulated evidence from smaller studies and international registries supports the efficacy of rFVIIa alongside extended standard treatment to control severe PPH. Because rFVIIa neither substitutes the activity of a missing coagulation factor nor bypasses a coagulation defect in this population, it is not immediately evident how it exerts its beneficial effect. Here, we discuss possible mechanistic explanations for the efficacy of rFVIIa and the published evidence in patients with severe PPH. Recombinant FVIIa may not primarily increase systemic thrombin generation, but may promote local thrombin generation through binding to activated platelets at the site of vascular wall injury. This explanation may also address safety concerns that have been raised over the administration of a procoagulant molecule in a background of increased thromboembolic risk due to both pregnancy-related hemostatic changes and the hemorrhagic state. However, the available safety data for this and other indications are reassuring and the rates of thromboembolic events do not appear to be increased in women with severe PPH treated with rFVIIa. We recommend that the administration of rFVIIa be considered before dilutional coagulopathy develops and used to support the current standard treatment in certain patients with severe PPH.
ER  -

Basic information
Original name	Rationale for the Potential Use of Recombinant Activated Factor VII in Severe Post-Partum Hemorrhage
Authors	ACS, Nandor, Wolfgang C KORTE, Christian C VON HEYMANN, Jerzy WINDYGA and Jan BLATNÝ (203 Czech Republic, belonging to the institution).
Edition	Journal of Clinical Medicine, Basel, MDPI, 2024, 2077-0383.

Other information
Original language	English
Type of outcome	Article in a journal
Field of Study	30204 Oncology
Country of publisher	Switzerland
Confidentiality degree	is not subject to a state or trade secret
WWW	URL
Impact factor	Impact factor: 3.900 in 2022
Organization unit	Faculty of Medicine
Doi	http://dx.doi.org/10.3390/jcm13102928
UT WoS	001234852000001
Keywords in English	massive post-partum hemorrhage; Novo Seven; obstetric hemorrhage; rFVIIa mode of action
Tags	14110321, rivok
Tags	International impact, Reviewed
Changed by	Changed by: Mgr. Tereza Miškechová, učo 341652. Changed: 20/8/2024 12:05.

Abstract

Severe post-partum hemorrhage (PPH) is a major cause of maternal mortality worldwide. Recombinant activated factor VII (rFVIIa) has recently been approved by the European Medicines Agency for the treatment of severe PPH if uterotonics fail to achieve hemostasis. Although large randomized controlled trials are lacking, accumulated evidence from smaller studies and international registries supports the efficacy of rFVIIa alongside extended standard treatment to control severe PPH. Because rFVIIa neither substitutes the activity of a missing coagulation factor nor bypasses a coagulation defect in this population, it is not immediately evident how it exerts its beneficial effect. Here, we discuss possible mechanistic explanations for the efficacy of rFVIIa and the published evidence in patients with severe PPH. Recombinant FVIIa may not primarily increase systemic thrombin generation, but may promote local thrombin generation through binding to activated platelets at the site of vascular wall injury. This explanation may also address safety concerns that have been raised over the administration of a procoagulant molecule in a background of increased thromboembolic risk due to both pregnancy-related hemostatic changes and the hemorrhagic state. However, the available safety data for this and other indications are reassuring and the rates of thromboembolic events do not appear to be increased in women with severe PPH treated with rFVIIa. We recommend that the administration of rFVIIa be considered before dilutional coagulopathy develops and used to support the current standard treatment in certain patients with severe PPH.

PrintDisplayed: 22/8/2024 11:59

Rationale for the Potential Use of Recombinant Activated Factor VII in Severe Post-Partum Hemorrhage

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