Table 1.

Flow chart of study procedures and information collected at each study visit

Procedures	Prior to enrolment	Visit 1 post- randomisation (0–24 hours)*	Visit 2 POD7/DC	Visit 3 POD28
Blood bank receives fibrinogen order†	X	(X)‡
Inclusion and exclusion criteria	X
Randomisation	X
IMP administration§		X
Patient (surrogate) debriefing and consent		X	(X)
Baseline data
Demographics		X
Medical history		X
Preoperative medications		X
Surgical data
Intraoperative medications		X
CPB time		X
Cross-clamp time		X
Circulatory arrest		X
Vital signs		X
Fluid input and output monitoring		X
Inotropes and vasopressors		X
Laboratory assessments
Chemistry¶		X	X
Haematology¶		X**	X
Coagulation profile¶		X**	X
Safety laboratories¶		X	X
Transfusion requirements††
RBCs		X	X
Pooled and apheresis platelets		X	X
Plasma		X	X
Other haemostatic products		X	X
Blood loss determination using UDPB		X	X
Extubation time		X	(X)	(X)
ICU length of stay		X	(X)	(X)
Hospital length of stay			X	(X)
AEs and SAEs		X	X	X
Concomitant medications		X	X	X
Physical examination		X

*For any activities not completed during this visit, additional visits will be undertaken to complete activities.

†After the start of surgery and during or after CPB.

‡Patients will be treated according to their group allocation for any subsequent doses needed during the treatment period (up to 24 hours after termination of CPB).

§IMP will first be administered after CPB termination.

¶As per standard practice.

**Prior to and up to 75 min after IMP administration.

††From beginning of surgery to postoperative day 7.

() if needed.

AE, adverse event; CPB, cardiopulmonary bypass; DC, discharge; ICU, intensive care unit; IMP, investigational medicinal product; POD, postoperative day; RBC, red blood cell; SAE, serious adverse event; UDPB, universal definition of perioperative bleeding.