Concomitant treatments and invasive procedures
Tranexamic acid (median dose: 3 g; range: 1.5–6) was administered to 65% of patients as rescue therapy, after IMP administration, with no significant between-group differences (Table S1). At least one fibrinogen concentrate (1.5 g) was administered as rescue therapy to 4.0% of patients in the fibrinogen group, and 8.0% in the placebo group (p=0.080). Intrauterine balloon was used in 29% of patients with no between-group differences, but the need for invasive haemostatic procedures (mainly arterial embolization) remained rare (3.6% and 4.8% in the fibrinogen and placebo groups, respectively; p=0.56). All patients received crystalloids after baseline (median volume: 2000 mL), and 28% received hydroxyethyl starch (median volume: 500 mL) with no between-group differences. Blood products were also used with no between-group differences with 25% of patients having received RBCs (median: 2 units), 10% fresh frozen plasma (median: 2 units), and 1.6% platelets (median: 3 units).