Prothrombin Complex Concentrate (PCC)

The overall objective of this study is to determine whether ROTEM (rotational thromboelastometry) guided dosing of four-factor prothrombin complex concentrate (4F-PCC) results in superior perioperative bleeding control compared to clinician-directed. PCC administration in adult patients undergoing high-risk cardiac surgery with cardiopulmonary bypass (CPB) who develop post-CPB coagulopathic bleeding.

Inclusion Criteria: * Age \>= 18 years * Undergoing high-risk cardiac surgery with cardiopulmonary bypass, defined as any one or more of: (a) reoperation/redo cardiac surgery; (b) combined valve surgery and Coronary Artery Bypass Grafting (CABG); (c) aortic root or ascending aortic surgery; (d) surgery requiring hypothermic circulatory arrest; (e) active preoperative anticoagulation \[Vitamin K Antagonist (VKA), Direct Oral Anti-Coagulant (DOAC), or therapeutic heparin/ Low Molecular Weight Heparin (LMWH)\] within 5 days of surgery * Clinically significant post-cardio pulmonary bypass (CPB) coagulopathic bleeding requiring coagulation factor replacement, as determined by the attending clinician, within 2 hours of CPB termination * Attending clinician decision to administer Four Factor Prothrombin Complex Concentrate (4F-PCC) intraoperatively * Written informed consent obtained preoperatively (or Legally Authorized Representative (LAR) consent; see Consent section for emergency waiver provisions) Exclusion Criteria: * Known hypersensitivity to Prothrombin Complex Concentrate (PCC), heparin, or any component of the 4F-PCC formulation * Documented history of heparin-induced thrombocytopenia (HIT) * Active thromboembolic event \[Deep Venous Thrombosis (DVT), Pulmonary Embolism (PE), acute ischemic stroke, or Myocardial Infarction (MI)\] within 3 months of surgery and not related to the index cardiac procedure * Pregnancy * Participation in another interventional clinical trial within 30 days * Life expectancy less than 30 days from a non-cardiac cause * Refusal of blood products precluding PCC administration