Effects Of Ulinastatin And Tranexamic Acid On Hemostasis And Inflammatory Mediators In Cardiac Surgical Procedures

Objective To evaluate the effects of ulinastatin and tranexamic acid on hemostasis and inflammatory mediators in cardiopulmonary bypass cardiac surgical procedures.Method The study is a randomized double-blind clinical trial. Three hundred and fifty patients receiving cardiopulmonary bypass cardiac surgery were recruited and assigned to four groups:ulinastatin group (group A,100 cases), trnexamic acid group (group B,100 cases), combination group (group C,50 cases) and control group (group D,100 cases). Patients in group A received ulinastatin 1,000,000 units after anesthetic induction, heparinization and neutralization respectively with a total dosage of 3,000,000 units. Patients in group B received tranexamic acid 15mg/Kg after heparinization and after neutralization respectively with a total dosage of 30mg/Kg. Patients in group C received ulinastatin and tranexamic acid by the same dosage and regimen described above. Patients in group D received saline. Chest drainage and allogeneic transfusion was observed. A consecution of fifty patients was selected from group A, B and D respectively. Tumor necrosis factor a, interleukin-6, interleukin-8, interleukin-10, neutrophil elastase and endothelin-1 was tested at five time points:before the operation, at the end of the operation,6 hours,12 hours and 24 hours postoperatively.Results Baseline demographic data was similar among the groups. Chest drainage between 0-8 hours,9-16 hours,17-24hours postoperatively and the total volumn was significantly lower in group A, B and C than group D (p<0.01). Patients in group A, B and C received significantly less red blood cell (p=0.012) and plasma (p=0.044) with a significantly lower transfusion rate than group D (p=0.041 and p=0.048). Total transfusion rate also revealed a statistical difference between group A, B, C and D (p<0.01). Perioperative data and sugical complications carried no difference among the groups (p>0.05). No mortality was observed in the study. Serum concentration of TNF-a, IL-6 and IL-8 was higher postoperatively than preoperatively and that in group A and B was significantly lower than in group D (p<0.01). Serum level of IL-10 is higher in group A and B than in group D (p<0.01). Serum level of neutrophil elastase is lower in group A and B than in group D (p<0.01). Serum concentration of endothelin-1 rised after the operation while that in group A and B is significantly lower than group D (p<0.01)Conclusion In cardiopulmonary bypass cardiac surgical procedures, ulinastatin and tranexamic acid could effectively reduce postoperative bleeding and allogeneic transfusion. At the same time, they could both regulate inflammatoin mediators.