Table 1

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

ProceduresPrior 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 criteriaX
RandomisationX
IMP administration§X
Patient (surrogate) debriefing and consentX(X)
Baseline data
  DemographicsX
  Medical historyX
  Preoperative medicationsX
Surgical data
  Intraoperative medicationsX
  CPB timeX
  Cross-clamp timeX
  Circulatory arrestX
  Vital signsX
  Fluid input and output monitoringX
  Inotropes and vasopressorsX
Laboratory assessments
  Chemistry¶XX
  Haematology¶X**X
  Coagulation profile¶X**X
  Safety laboratories¶XX
Transfusion requirements††
  RBCsXX
  Pooled and apheresis plateletsXX
  PlasmaXX
  Other haemostatic productsXX
Blood loss determination using UDPBXX
Extubation timeX(X)(X)
ICU length of stayX(X)(X)
Hospital length of stayX(X)
AEs and SAEsXXX
Concomitant medicationsXXX
Physical examinationX
  • *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.