Efficacy of prothrombin complex concentrate (PCC) versus fresh frozen plasma (FFP) in reducing perioperative blood loss in cardiac surgery: study protocol for a non-inferiority, randomised controlled trial

OBJECTIVE: To explore whether prothrombin complex concentrate (PCC) is not inferior to fresh frozen plasma (FFP) with regard to reducing perioperative blood loss in patients undergoing cardiac surgery under cardiopulmonary bypass (CPB). SETTING: Fu Wai Hospital, and Peking Union Medical College Hospital in China. PARTICIPANTS: Patients undergoing elective coronary artery bypass grafting, valve replacement or valvuloplasty under CPB, between 18 and 80 years old, will be included. DESIGN: This study is a non-inferiority, randomised controlled clinical trial. A total of 594 subjects will be randomly assigned to two groups (group PCC and group FFP) and given corresponding interventions when at least one of the following criteria is met: (1) international normalised ratio >1.7 measured 20 min after CPB, (2) prolonged prothrombin time or activated partial thromboplastin time (>1.5 times baseline) measured 20 min after CPB and (3) excessive bleeding observed. 4-factor PCC (15 IU/kg) and FFP (10 mL/kg) will be given to group PCC and group FFP, respectively. Preoperative management, anaesthetic and surgical techniques will be standardised for both groups. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome is the volume of blood loss during and within 24 hours after surgery. The secondary outcomes include (1) the total units of allogeneic red blood cells transfused during and within 7 days after surgery, (2) re-exploration due to postoperative bleeding within 7 days after surgery, (3) adverse events and serious adverse events within 30 days after surgery and (4) length of intensive care unit stay and hospital stay. TRIAL REGISTRATION NUMBER: Registered under NCT04244981 at ClinicalTrials.gov on 28 January 2020, https://clinicaltrials.gov/ct2/show/NCT04244981?cond=NCT04244981&draw=2&rank=1. ETHICS AND DISSEMINATION: This study has been approved by the Institutional Review Board of Peking Union Medical College Hospital (ZS-2242).