Recombinant factor VII for severe bleeding during extracorporeal membrane oxygenation following open heart surgery

Abstract

rFVIIa is effective to achieve control of refractory hemorrhage in patients on extracorporeal membrane oxygenation. Now a randomized controlled trial to evaluate risks and benefits of rFVIIa on patients undergoing extracorporeal membrane oxygenation is required.

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).…”

“…[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. Veldman and colleagues 485 reported on 7 patients receiving recombinant FVIIa for intractable hemorrhage while on ECMO.…”

Recombinant activated factor seven in acute life-threatening bleeding in neonates: report on three cases and review of literature

“…These experiences include: intracranial hemorrhage in neonates with FVII deficiency, 3,4 intraventricular hemorrhage associated with coagulopathy caused by liver failure, 5 infants during open heart surgery and extracorporeal membrane oxygenation (ECMO), [6][7][8] resection of a giant sacrococcygeal teratoma, 9 and with intraperitoneal and subcapsular liver bleeding. 10 In premature infants, rFVIIa use was reported for treatment of bleeding from liver and spleen, 11,12 from pulmonary and intercostal arteries, 11 from surgical wounds, 12,13 and from pulmonary hemorrhage.…”

Safety and efficiency of recombinant activated factor VII in postcardiotomy massive hemorrhage

“…The use of rfVIIa has been reported in extracorporeal membrane oxygenation (17)(18)(19)(20) and left ventricular assist devices (21), but systemic and extracorporeal device thrombosis were observed (22). No randomized controlled trials are available to address the safety issue of rf-VIIa in extracorporeal support patients.…”

“…Nineteen per cent of their patients also had a complication that might have been caused by thromboembolism, namely, transient paraplegia and multiple organ failure, for a total of 44% of patients. Several case series (16)(17)(18)(19)(20) report no thromboembolic complications from rf-VIIa. Few series (14,15,23) address the safety of rf-VIIa in coronary artery bypass grafting surgery, with no adverse events reported.…”