Figure 2. Study design. *OR personnel will remain blinded to treatment until treatment decision; patients will be blinded to treatment allocation. †A second dose of 4F-PCC or FP (as per original randomised allocation) can be given within the 24-hour treatment period (ie, within 24 hours after the first dose of IMP) if the patient continues to have at least a grade 2 bleed and an INR≥1.5 after the first dose; for subsequent doses, the patient will receive FP. ‡FP in 1–4 U increments at the discretion of the ordering physician. 4F-PCC, four-factor prothrombin complex concentrate; BW, body weight; FP, frozen plasma; IMP, investigational medicinal product; IU, international units; OR, operating room; U, units.