A S Ducloy-Bouthors1,2, F J Mercier3, J M Grouin4, F Bayoumeu5, J Corouge1, A Le Gouez3, T Rackelboom6, F Broisin7, F Vial8, A Luzi9, O Capronnier10, C Huissoud7,11, A Mignon6. 1. Pole anesthésie réanimation, maternité Jeanne de Flandre, CHRU Lille, Lille, France. 2. ULR 7365 Université Lille, Lille, France. 3. Hôpital Antoine Béclère, Assistance Publique Hôpitaux de Paris, Clamart, France. 4. Inserm U1219, Population Health, Bordeaux, France. 5. Hôpital Paule de Viguier, CHU Toulouse, Toulouse, France. 6. Hôpital Cochin, Assistance Publique Hôpitaux de Paris, Paris, France. 7. Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France. 8. Maternité Adolphe Pinard, CHU de Nancy, Nancy, France. 9. CHU Sud, St Pierre-de-la-Réunion, France. 10. Euraxi Pharma, Joué-lès-Tours, France. 11. INSERM U846, Stem Cell and Brain Research Institute, Bron, France.
Abstract
OBJECTIVE: To assess the benefits and safety of early human fibrinogen concentrate in postpartum haemorrhage (PPH) management. DESIGN: Multicentre, double-blind, randomised placebo-controlled trial. SETTING: 30 French hospitals. POPULATION: Patients with persistent PPH after vaginal delivery requiring a switch from oxytocin to prostaglandins. METHODS: Within 30 minutes after introduction of prostaglandins, patients received either 3 g fibrinogen concentrate or placebo. MAIN OUTCOME MEASURES: Failure as composite primary efficacy endpoint: at least 4 g/dl of haemoglobin decrease and/or transfusion of at least two units of packed red blood cells within 48 hours following investigational medicinal product administration. Secondary endpoints: PPH evolution, need for haemostatic procedures and maternal morbidity-mortality within 6 ± 2 weeks after delivery. RESULTS:437 patients were included: 224 receivedFC and 213 placebo. At inclusion, blood loss (877 ± 346 ml) and plasma fibrinogen (4.1 ± 0.9 g/l) were similar in both groups (mean ± SD). Failure rates were 40.0% and 42.4% in the fibrinogen and placebo groups, respectively (odds ratio [OR] = 0.99) after adjustment for centre and baseline plasma fibrinogen; (95% CI 0.66-1.47; P = 0.96). No significant differences in secondary efficacy outcomes were observed. The mean plasma FG was unchanged in the Fibrinogen group and decreased by 0.56 g/l in the placebo group. No thromboembolic or other relevant adverse effects were reported in the Fibrinogen group versus two in the placebo group. CONCLUSIONS: As previous placebo-controlled studies findings, early and systematic administration of 3 g fibrinogen concentrate did not reduce blood loss, transfusion needs or postpartum anaemia, but did prevent plasma fibrinogen decrease without any subsequent thromboembolic events. TWEETABLE ABSTRACT: Early systematic blind 3 g fibrinogen infusion in PPH did not reduce anaemia or transfusion rate, reduced hypofibrinogenaemia and was safe.
RCT Entities:
OBJECTIVE: To assess the benefits and safety of early humanfibrinogen concentrate in postpartum haemorrhage (PPH) management. DESIGN: Multicentre, double-blind, randomised placebo-controlled trial. SETTING: 30 French hospitals. POPULATION: Patients with persistent PPH after vaginal delivery requiring a switch from oxytocin to prostaglandins. METHODS: Within 30 minutes after introduction of prostaglandins, patients received either 3 g fibrinogen concentrate or placebo. MAIN OUTCOME MEASURES: Failure as composite primary efficacy endpoint: at least 4 g/dl of haemoglobin decrease and/or transfusion of at least two units of packed red blood cells within 48 hours following investigational medicinal product administration. Secondary endpoints: PPH evolution, need for haemostatic procedures and maternal morbidity-mortality within 6 ± 2 weeks after delivery. RESULTS: 437 patients were included: 224 received FC and 213 placebo. At inclusion, blood loss (877 ± 346 ml) and plasma fibrinogen (4.1 ± 0.9 g/l) were similar in both groups (mean ± SD). Failure rates were 40.0% and 42.4% in the fibrinogen and placebo groups, respectively (odds ratio [OR] = 0.99) after adjustment for centre and baseline plasma fibrinogen; (95% CI 0.66-1.47; P = 0.96). No significant differences in secondary efficacy outcomes were observed. The mean plasma FG was unchanged in the Fibrinogen group and decreased by 0.56 g/l in the placebo group. No thromboembolic or other relevant adverse effects were reported in the Fibrinogen group versus two in the placebo group. CONCLUSIONS: As previous placebo-controlled studies findings, early and systematic administration of 3 g fibrinogen concentrate did not reduce blood loss, transfusion needs or postpartum anaemia, but did prevent plasma fibrinogen decrease without any subsequent thromboembolic events. TWEETABLE ABSTRACT: Early systematic blind 3 g fibrinogen infusion in PPH did not reduce anaemia or transfusion rate, reduced hypofibrinogenaemia and was safe.
Authors: Philipp Helmer; Tobias Schlesinger; Sebastian Hottenrott; Michael Papsdorf; Achim Wöckel; Magdalena Sitter; Tobias Skazel; Thomas Wurmb; Ismail Türkmeneli; Christoph Härtel; Stefan Hofer; Ibrahim Alkatout; Leila Messroghli; Thierry Girard; Patrick Meybohm; Peter Kranke Journal: Anaesthesist Date: 2022-03-04 Impact factor: 1.041