Recombinant Activated Factor VII Following Pediatric Cardiac Surgery

Abstract

Objective: Review the use of recombinant activated Factor VII following cardiac surgery. Specifically, we sought to define our current therapeutic practice indications and outcomes to assess the impact of recombinant activated factor VII on postoperative bleeding. Design: Retrospective case series. Setting: The study was conducted at the University affiliated pediatric intensive care unit. Patients and participants: All postcardiac surgical patients who received recombinant activated Factor VII between June 2002 and July 2006. Results: Cardiac surgery requiring cardiopulmonary bypass was performed on 1010 children during this period. In all, 25 (2.5%) children received recombinant activated factor VII for excessive bleeding. A single dose (180 μg/kg) of recombinant activated factor VII was given to 11 patients and 2 doses of 180 μg/kg to 14 patients. Intercostal drain losses were reduced from 12 (6.7-20.8) mL/kg/h to 3 (1-4.1) mL/kg/h, P = .018 following 1 dose of recombinant activated factor VII. In those receiving 2 doses; initial losses were 19.1 (7.5-31.7) mL/kg/h, after the first dose were 7.5 (3.6-13.7) mL/kg/h, P = .046, and after the second dose were 2 (1-2.9) mL/kg/h, P = .008. The plasma prothrombin time decreased in both the 1 dose, P = .003 and 2 dose, P = .009 groups. The activated partial thromboplastin time also decreased in the 1 dose group, P = .007 and 2 dose group, P = .03. There were no side effects attributable to recombinant activated factor VII. Annual rates of return to the operating theatre for excessive bleeding were coincidentally reduced in association with the routine use of recombinant activated factor VII from 4.3% to 1.5%, P = .019. Conclusions: Hemostasis occurred in 25 postoperative pediatric cardiac patients after recombinant activated Factor VII was given. In this setting, once conventional hemostatic therapy was optimized, recombinant activated Factor VII 180 μg/kg initially with intercostal losses greater than 10 mL/kg/h and a repeat dose after 2 hours if losses remained greater than 5 mL/kg/h was effective. No complications were found to have occurred and there was a coincidental reduction in annual returns to theatre for excessive bleeding.