Early and systematic administration of fibrinogen concentrate in postpartum haemorrhage following vaginal delivery: the FIDEL randomised controlled trial.

Autor: Ducloy-Bouthors AS; Pole anesthésie réanimation, maternité Jeanne de Flandre, CHRU Lille, Lille, France.; ULR 7365 Université Lille, Lille, France., Mercier FJ; Hôpital Antoine Béclère, Assistance Publique Hôpitaux de Paris, Clamart, France., Grouin JM; Inserm U1219, Population Health, Bordeaux, France., Bayoumeu F; Hôpital Paule de Viguier, CHU Toulouse, Toulouse, France., Corouge J; Pole anesthésie réanimation, maternité Jeanne de Flandre, CHRU Lille, Lille, France., Le Gouez A; Hôpital Antoine Béclère, Assistance Publique Hôpitaux de Paris, Clamart, France., Rackelboom T; Hôpital Cochin, Assistance Publique Hôpitaux de Paris, Paris, France., Broisin F; Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France., Vial F; Maternité Adolphe Pinard, CHU de Nancy, Nancy, France., Luzi A; CHU Sud, St Pierre-de-la-Réunion, France., Capronnier O; Euraxi Pharma, Joué-lès-Tours, France., Huissoud C; Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France.; INSERM U846, Stem Cell and Brain Research Institute, Bron, France., Mignon A; Hôpital Cochin, Assistance Publique Hôpitaux de Paris, Paris, France.
Jazyk: angličtina
Zdroj: BJOG : an international journal of obstetrics and gynaecology [BJOG] 2021 Oct; Vol. 128 (11), pp. 1814-1823. Date of Electronic Publication: 2021 Apr 07.
DOI: 10.1111/1471-0528.16699
Abstrakt: 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 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.
(© 2021 John Wiley & Sons Ltd.)
Databáze: MEDLINE
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