Perioperative blood loss and allogeneic blood transfusion are major complications of cardiac surgery, which increase perioperative complications, perioperative mortality and medical costs.This study is a non-inferiority, randomized controlled trial, in order to determine whether PCC is no worse than FFP in reducing perioperative blood loss and allogeneic blood transfusion in patients undergoing cardiac surgery under CPB. Patients signed the informed consent, aged 18 to 80 years, receiving elective CABG or valve replacement or valvuloplasty under CPB in Fu Wai Hospital and Peking Union Medical College Hospital will be included. 560 subjects will be randomly divided into 2 groups (group PCC and group FFP), with 280 cases in each group. Preoperative management, anesthetic and surgical techniques will be standardized for both groups. When APTT is prolonged (>1.5 times normal), patients will be given a 4-factor PCC based on the patients' body weight and INR (INR 2-4, PCC 25 IU/kg; INR 4-6, PCC 35 IU/kg; INR>6, PCC 50 IU/kg) in group PCC and a dose of 10-15 ml/kg FFP in group FFP. All the patients will be followed up respectively at 24 hours, 48 hours, 72 hours and 7 days after the surgery to record observations relevant to the study and the results of laboratory testing. The laboratory tests include hemoglobin concentration, hematocrit, platelet count, INR, PT, APTT, fibrinogen levels and blood biochemistry parameters. 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 (RBCs) transfused during and within 7 days after surgery and (2) re-exploration due to postoperative bleeding within 7 days after surgery. Modified intent-to-treat analysis will be used for all valid variables. All randomized subjects in the study, regardless of adherence to the study process or whether an adverse event occurs before or after the intervention, should be included in the analysis. Sensitivity analysis will be performed to assess the bias that may be introduced due to nonadherence to the protocol or missing data. Baseline characteristics will be tabulated and compared between the PCC and FFP groups using standardized differences, and a value larger than 0.2 will be regarded as a clinically relevant difference between groups.The primary outcome, the volume of blood loss during and within 24 hours after surgery, will be compared using the t-test with log transformation of the variable. Continuous secondary outcomes and the total units of allogeneic RBCs transfused during and within 7 days after surgery will be compared using a t-test with log transformation of the variable. The rate of re-exploration due to bleeding within 7 days after surgery will be compared using the chi-square test. Treatment effect will be measured by odds ratio and mean difference for binary and continuous outcomes with corresponding 95% confidence intervals. No correction for multiple comparisons will be conducted in the analysis of the secondary outcomes; hence, the findings for secondary outcomes will be interpreted only as explanatory results. A two-sided P-value < 0.05 was considered indicative of statistical significance.
This study is a non-inferiority, randomized controlled trial, based on the hypothesis that 4-factor PCC is not inferior to FFP in reducing perioperative blood loss in patients undergoing cardiac surgery under cardiopulmonary bypass. 560 subjects will be randomly divided into 2 groups (group PCC and group FFP), with 280 cases in each group. Patients will be given a 4-factor PCC based on the patients' body weight and INR in group PCC and a dose of 10-15 ml/kg FFP in group FFP. All the patients will be followed up respectively at 24 hours, 48 hours, 72 hours and 7 days after the surgery. 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 (RBCs) transfused during and within 7 days after surgery and (2) re-exploration due to postoperative bleeding within 7 days after surgery.