Publication details

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

Authors

ACS Nandor KORTE Wolfgang C VON HEYMANN Christian C WINDYGA Jerzy BLATNÝ Jan

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/2077-0383/13/10/2928
Doi http://dx.doi.org/10.3390/jcm13102928
Keywords massive post-partum hemorrhage; Novo Seven; obstetric hemorrhage; rFVIIa mode of action
Description 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.

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