| Autor: |
Caram-Deelder C; Leiden University Medical Center, 2333 Leiden, The Netherlands., McKinnon Edwards H; Department of Obstetrics and Gynaecology, Copenhagen University Hospital Herlev, 2730 Herlev, Denmark., Zdanowicz JA; Department of Obstetrics and Gynecology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland., van den Akker T; Leiden University Medical Center, 2333 Leiden, The Netherlands.; Athena Institute, Vrije Universiteit, 1081 Amsterdam, The Netherlands., Birkegård C; Novo Nordisk A/S, 2860 Søborg, Denmark., Blatný J; Department of Paediatric Oncology, University Hospital Brno, and Masaryk University, 625 00 Brno, Czech Republic., van der Bom JG; Leiden University Medical Center, 2333 Leiden, The Netherlands., Colucci G; Department of Obstetrics and Gynecology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland.; Clinica Sant'Anna, 6924 Sorengo, Switzerland.; University of Basel, 4001 Basel, Switzerland., van Duuren D; Leiden University Medical Center, 2333 Leiden, The Netherlands., van Geloven N; Leiden University Medical Center, 2333 Leiden, The Netherlands., Henriquez DDCA; Leiden University Medical Center, 2333 Leiden, The Netherlands.; Amsterdam University Medical Center, University of Amsterdam, 1105 Amsterdam, The Netherlands., Knight M; National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford OX3 7LF, UK., Korsholm L; Novo Nordisk A/S, 2860 Søborg, Denmark., Landorph A; Novo Nordisk A/S, 2860 Søborg, Denmark., Lavigne Lissalde G; Department of Hematology, University Hospital, 30900 Nîmes, France., McQuilten ZK; Transfusion Research Unit, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne 3004, Australia.; Department of Haematology, Monash Health, Melbourne 3004, Australia., Surbek D; Department of Obstetrics and Gynecology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland., Wellard C; Transfusion Research Unit, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne 3004, Australia., Wood EM; Transfusion Research Unit, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne 3004, Australia.; Department of Haematology, Monash Health, Melbourne 3004, Australia., Mercier FJ; Hôpital Antoine Béclère, Assistance Publique-Hôpitaux de Paris, Université Paris Saclay, 92140 Clamart, France. |
| Abstrakt: |
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. |
