Prophylactic administration of recombinant activated factor vii in coronary revascularization surgery

ABSTRACT

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 revascularisation procedures done under cardiopulmonary bypass [CPB]. this is a randomised controlled prospective observational study. 30 patients scheduled for elective cardiac revascularisation under CPB were enrolled in the study. Patients were randomly allocated into two groups; Control group where no rFVIIa was administered and rFVIIa group to whom a single dose of 45ug/Kg of rFVIIa was administered following weaning off CPB and heparin reversal. The total amount of chest tube drain during the first 24 hours following surgery was recorded as well as the qualitative and quantitative assessment of homologous blood and products transfusion. Serial analysis of haematological parameters including haemoglobin level and coagulation test carried on in a definite data points. TO = baseline readings prior to CPB, Tl = off CPB; after protamine sulphate administration and before administration of the study drug, T2 = on CICU admission, T3 = 12 hours post CICU admission, T4 = 24 hours post CICU admission. Total chest tube drainage was lower [p= 0.001] in rFVIIa group. Blood and products transfusion were statistically lower in the rFVIIa group [p= 0.05]. Moreover; results showed statistically lower INR values at CICU admission and 12 hrs post CICU admission [p= 0.018 and 0.004 respectively]. Also, the PTT mean values were statistically lower at same timings [p= 0.04 and 0.001 respectively]. No thrombotic complications were reported in both groups. Prophylactic use of 45 ug/kg rFVIIa in patients undergoing coronary revascularisation surgery under the management of CPB had a remarkable significant results on both the amount of postoperative bleeding as well as the amount of blood and products transfusion. However, these reductions require quantification. Furthermore, future studies that examine the question of blood loss and transfusion requirement reduction with rFVIIa should include an analysis of cost benefits. Future studies should also formally investigate the dose-dependent effects of rFVIIa in cardiac surgery, and investigate effects in both routine and high-risk cardiac surgery