Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery

Exclusion Criteria

• •1. Undergoing heart transplantation, insertion or removal of ventricular assist devices (not including intra-aortic balloon pump \[IABP\]) or repair of thoracoabdominal aneurysm
• •2. Critical state immediately before surgery with high probability of death within 24 hours of surgery (e.g., acute aortic dissection, cardiac arrest within 24 hours before surgery)
• •3. Severe right heart failure (clinical diagnosis ± echocardiography)
• •4. Known contraindications to heparin
• •5. PCC required for reversal of warfarin or direct oral anticoagulant (DOAC; dabigatran, rivaroxaban, apixaban or edoxaban) within 3 days prior to or during surgery
• •6. Known thromboembolic event (TEE) within 3 months prior to surgery
• •7. History of severe allergic reactions to PCC or FP
• •8. Individuals who have immunoglobulin A (IgA) deficiency with known antibodies against IgA
• •9. Refusal of allogeneic blood products
• •10. Known pregnancy
• •11. Currently enrolled in other interventional clinical trials