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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Cardiac Surgical Intensive Care Unit, King Faisal Heart Center, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia; Department of Critical Care Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt.
Aly Makram
AM
Habib
Department of Critical Care Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt.
Ahmed Yehia
AY
Mousa
Cardiac Surgery Section, King Faisal Heart Center, King Faisal Specialist Center and Research Center, Riyadh, Saudi Arabia.
Zohair
Z
Al-Halees
Bleeding; Cardiac surgery; rFVIIa
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