Evaluation of the role of recombinant activated factor VII (NovoSeven) as a rescue haemostatic therapy in postcardiopulmonary bypass surgical patients

Objective

Evaluation of the safety and efficacy of recombinant activated factor VII (NovoSeven) when used as a rescue haemostatic agent in refractory bleeding post bypass surgery.

Methods

A retrospective cohort study of all postcardiopulmonary bypass patients with uncontrolled bleeding despite conventional treatment (platelets, fresh frozen plasma, cryoprecipitate, and Aprotonin) who received recombinant factor VII as a rescue therapy over 12 months in a cardiothoracic centre.

Results

Eight patients received NovoSeven (90 μg/kg). Seven achieved significant reduction in blood loss. The mean blood loss via thoracic drains 6 hours before and 2 hours after NovoSeven administration were 341 ml/hour vs 117 ml/hour (P = 0.01) (Figure 1). On average, 5.3 units/patient packed red blood cells, 2 pools/patient platelets, 19 ml/kg/patient fresh frozen plasma and 148 ml/patient cryoprecipitate were used prior to NovoSeven administration. Five patients required further blood transfusion with a mean of 2.2 units/patient over the next 12 hours. Two of the eight patients developed thromboembolic complications including portal vein thrombosis and spinal cord infarction. Of these two, one died secondary to coagulopathic complications post initiation of warfarin therapy 2 weeks post surgery.

Figure 1

Mean hourly drain output 6 hours pre and 2 hours post NovoSeven administration.

Conclusion

Our results support the evidence that recombinant factor VII is an effective haemostatic agent that can be used in patients with uncontrolled bleeding in postcardiopulmonary bypass surgery. Despite its high cost, there is an advantage in terms of effectiveness to support its use. However, its potential thromboembolic risk remains a concern and current evidence may restrict its use only as a rescue therapy following failed conventional treatment.