Recombinant Factor Seven Therapy for Postoperative Bleeding in Neonatal and Pediatric Cardiac Surgery

Recombinant factor VIIa for intractable life-threatening bleeding in patients with circulatory assist devices

“…Despite warnings related to potential lethal thrombotic complications, offlabel use of recombinant factor VIIa (rFVIIa) is increasingly reported for refractory hemorrhage, including after cardiac surgery [1,2]. However, its use in patients with circulatory assist devices has seldom been reported and its safety remains to be established [3][4][5].…”

Prevention and Treatment of Thrombosis in Pediatric and Congenital Heart Disease

“…475 There are small, single-center experiences in pediatric patients with intractable hemorrhage after cardiac surgery, among patients with known factor deficiency or coagulopathy after cardiac surgery, and among patients placed on ECMO after cardiac surgery with intractable hemorrhage. [476][477][478][479][480][481][482][483][484][485] These studies suggest that recombinant FVIIa is effective in decreasing postoperative bleeding, but thrombotic complications have been reported, including an arterial thrombus in an infant requiring amputation of a leg. 484 The dose used among pediatric patients with intractable hemorrhage after cardiac surgery ranges from 30 to 180 μg/kg (recommended dose for patients with hemophilia, 90 μg/kg).…”

“…[476][477][478][479][480][481][482][483][484][485] These studies suggest that recombinant FVIIa is effective in decreasing postoperative bleeding, but thrombotic complications have been reported, including an arterial thrombus in an infant requiring amputation of a leg. 484 The dose used among pediatric patients with intractable hemorrhage after cardiac surgery ranges from 30 to 180 μg/kg (recommended dose for patients with hemophilia, 90 μg/kg). 476,478,479 A single randomized, blinded, controlled study has evaluated the prophylactic use of recombinant FVIIa to reduce time to chest closure and to decrease transfusion among infants undergoing cardiac surgery.…”

“…The data on the use of recombinant FVIIa among patients with severe bleeding on ECMO are limited to case reports and small single-institution series. [483][484][485]509,510 In case reports and small uncontrolled series, bleeding was reported to decrease after the administration of recombinant FVIIa. 482,483,509 Two studies compared outcome among patients receiving recombinant FVIIa on ECMO with historic controls.…”

“…Neither the reduction of chest tube output nor the decrease in blood product transfusion requirements reached statistical significance. Agarwal and colleagues 484 reported 11 patients who received recombinant FVIIa on ECMO for severe bleeding and compared their outcome with those of 15 historic controls. Both bleeding and transfusion were decreased.…”