Objectives

Recombinant factor VIIa is used off-label for refractory bleeding after cardiac surgery. This study reviewed the indications, usage rates and complications of recombinant factor VIIa.

Design

Retrospective case control observational study

Setting

Single quaternary pediatric hospital

Participants

All children undergoing cardiac surgery with cardiopulmonary bypass over a 3-year period.

Interventions

Administration of recombinant factor VIIa as rescue therapy for refractory bleeding after weaning from cardiopulmonary bypass.

Measurements and Main Results

1515 cardiopulmonary bypass procedures were reviewed. Cases receiving recombinant factor VIIa were each matched to two control patients by age, procedure type and bypass time. Data collected included weight, cross-clamp time, anticoagulant and antifibrinolytic dose, return to theater for bleeding, thrombotic events, and extracorporeal membrane oxygenation circuit interventions.

42 patients received recombinant factor VIIa (2.8%). Major systemic thrombotic complications were observed in 19% (controls 12.5%); 80% recombinant factor VIIa patients requiring post-operative extracorporeal membrane oxygenation had interventions for circuit thrombosis (controls 31.25%); 4.76% recombinant factor VIIa recipients required re-exploration for intractable bleeding (controls 1.39%).

Conclusions

This study adds to our understanding regarding the use of recombinant factor VIIa in pediatric cardiac surgery and reports increased thrombotic complications, especially for children who progress to extracorporeal membrane oxygenation. Prospective studies to better understand the pathophysiology of coagulopathy and hemorrhage in pediatric cardiac surgery, and the role of hemostatic agents such as recombinant factor VIIa are required.