Fibrinogen concentrate as a treatment for postpartum haemorrhage-induced coagulopathy: A study protocol for a randomised multicentre controlled trial. The fibrinogen in haemorrhage of DELivery (FIDEL) trial

BackgroundPostpartum haemorrhage (PPH) remains the leading cause for maternal mortality worldwide. Hypofibrinogenaemia has been identified as a major risk factor for progress towards severe PPH. The efficacy of fibrinogen concentrate supplementation in PPH has been shown in various clinical settings but the level of evidence is not sufficient to prove the benefit, evaluate the risks, and determine the value, timing and dose of fibrinogen supplementation in PPH. The FIDEL trial objective is to evaluate the impact of a therapeutic strategy based on the early administration of human fibrinogen concentrate compared to the current practice based on late administration in severe PPH patients requiring second line uterotonics.Methods/designThis is a prospective multicentre, randomised, double-blind, placebo-controlled trial. A total of 412 patients will be randomised if they meet the following criteria: female patients ≥ 18 years old, vaginal delivery, PPH requiring IV administration of prostaglandins (sulprostone) after 20 to 30 minutes of oxytocin failure. The participants are assigned to receive either fibrinogen 3 g or placebo infusions. The primary endpoint is a composite endpoint defined as the percentage of patients losing at least 4 g/dL of Hb, and/or requiring a transfusion of at least 2 units of packed red blood cells, within the 48 hours following fibrinogen administration.DiscussionThe purpose of this study is to demonstrate the efficacy and safety of an early fibrinogen concentrate infusion in uncontrolled active PPH.