Randomization and Blinding
Patients were randomized in a 1:1
ratio to either the fibrinogen or placebo groups in a double-blind
manner. Randomization was stratified per centre with a block size of 4;
IMP containers were sequentially numbered according to the
computer-generated randomization sequence. Reconstitution of fibrinogen
and formulation of the placebo (2 vials = 3 g of fibrinogen or placebo
per patient) were carried out by trained research personnel not involved
in the patients’ care. Blinding of care providers and patients was
maintained throughout by use of a masking system and tinted tubing. Each
vial of fibrinogen concentrate (1.5 g) and placebo was reconstituted in
100 mL of sterile water and administered at a flow rate ≤ 20 mL/min
within 30 min following the start of the sulprostone infusion.