This is a pragmatic, prospective, multi-center, randomized, active-control, single-blinded,
non-inferiority phase 3 trial in adult cardiac surgical patients. Up to 12 Canadian hospitals
will participate, and the trial will require up to 2 years for patient recruitment.
Twelve-hundred bleeding adult cardiac surgical patients who require fibrinogen
supplementation due to acquired hypofibrinogenemia after CPB will be included. Patients will
be randomized to receive equivalent doses of either fibrinogen concentrate (Octafibrin) or
cryoprecipitate when the blood bank receives the first order for fibrinogen supplementation
and deems it to be in accordance with accepted clinical standards. Thereafter, patients will
be treated according to their assigned group each time fibrinogen supplementation is ordered
during the treatment period (24 hours after termination of CPB). No other aspects of care
will be modified.
The primary efficacy outcome will be the number of Allogeneic blood products (ABP) (red blood
cells [RBCs], pooled or apheresis platelets, and plasma) administered during the first 24
hours after termination of CPB. Safety outcomes will be measured for the first 28 days after
surgery, which is the duration of participation of each patient in the trial. Comparisons
will be by intention-to-treat (ITT) (primary) and per-protocol (PP) analysis. One interim
analysis will be conducted after 600 patients have been treated to determine whether the
study should be terminated for safety reasons, demonstrated non-inferiority or futility
reasons.