Recombinant activated factor VII for uncontrolled bleeding postcardiac surgery

A retrospective observational study to review the safety and efficacy of rFVIIa in persistent hemorrhage in post cardiac surgical patients.

Patients who had bleeding of 3 ml/kg/h or more for 2 consecutive hours after cardiac surgery were arranged into two groups; control group, who received conventional treatment and rFVIIa group, who received conventional treatment and rFVIIa.

There was no significant difference in demographic and surgical characteristics of both groups. The chest tube output significantly decreased in the rFVIIa group compared to the other group 4 hours after admission {1.4 (IQR: 1-2.2) ml/kg/h vs 3.9 (IQR: 3.1-5.6) ml/kg/h; p = 0.004} and continues to be significant till 9 hours after CSICU admission {0.6 (IQR: 0.4-1.1) ml/kg/h vs 1.9 (IQR: 1.2-2.2) ml/kg/h; p = 0.04}. The median number of blood products units transfused to rFVIIa group was significantly lower compared to control group in the period from 3-12 hours after CSICU admission. 13 (5.5%) patients in rFVIIa group had Thromboembolic adverse events (TAE) compared to 7 (2.4%) patients in other group p = 0.27. 8 patients in the rFVIIa group needed reexploration compared to 19 patients in the other group, p = 0.01. No significant difference was noticed between the 2 groups regarding: new onset renal failure, median number of mechanical ventilator days, pneumonia, mediastinitis, ICU and hospital lengths of stay, survival at 30 days and at discharge.

In this analysis, rFVIIa succefully reduced the chest tube bleeding and blood products transfused during severe post cardiac surgical bleeding. However, safety of rFVIIa remains unclear. Prospective controlled trials are still needed to confirm the role of rFVIIa.