Prophylactic administration of recombinant activated factor VII in coronary revascularization surgery

Abstract

Objective:The objective of this clinical trial is to study the effectiveness of administering recombinant activated factor VII (rFVIIa) in reducing the amount of bleeding and the need for homologous blood and products transfusion in cardiac surgical coronary revascularization procedures done under cardiopulmonary bypass (CPB).Methods:In a randomized controlled prospective observational study, 30 patients were scheduled for elective cardiac revascularization under CPB. Patients were randomly allocated into two groups. In Group I (Control group), no rFVIIa was administered following CPB. In Group II (Study group), a dose of 90 ug/Kg of rFVIIa was administered following weaning off CPB. The total amount of chest tube drain during the 1st 24 h following surgery was recorded as well as the qualitative and quantitative assessments of homologous blood and products transfusion. Serial analysis of hematological parameters including hemoglobin level and coagulation test in a definite data points was done. T0=baseline readings prior to CPB, T1=off CPB after protamine administration and before administration of the study drug, T2=on Cardiac Intensive Care Unit (CICU) admission, T3=12 h post-CICU admission, and T4=24 h post-CICU admission.Results:Considering the total chest tube drainage, mean values showed statistically significant results with a P value of 0.001. Homologous blood and products transfusion were statistically lower in the study group. Regarding the mean values for hematological assessment, results showed statistically lower International Normalized Ratio values at CICU admission and 12 h post-CICU admission with a P value of 0.018 and 0.004, respectively. Also, the Partial Thromboplastin Time mean values were statistically lower at same timings with estimated P values of 0.04 and 0.001, respectively.Conclusion:It is concluded that the prophylactic use of rFVIIa in patients undergoing coronary revascularization surgery under the management of CPB had a remarkable significant results on both the amount of post-operative bleeding and the amount of blood and products transfusion.