The use of recombinant coagulation factor VIIa in uncontrolled postoperative bleeding in children undergoing cardiac surgery with cardiopulmonary bypass*

Abstract

rFVIIa may be useful in preventing reexploration in uncontrolled postoperative bleeding in children undergoing cardiac surgery with cardiopulmonary bypass. Randomized, placebo-controlled studies are needed to confirm the safety and efficacy of rFVIIa in this clinical setting.

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).…”

“…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. This study included 76 patients: 40 received 40 μg/kg recombinant FVIIa, and 36 received placebo.…”

Utilization of recombinant activated factor VII for intracranial hematoma evacuation in coagulopathic nonhemophilic neurosurgical patients with normal international normalized ratios

“…However, a report of its successful use in a soldier with no pre-existing coagulopathy to stop hemorrhage from a gunshot wound prompted the subsequent exploration of rFVIIa use in nonhemophilic patients [8]. The scope and indications of rFVIIa usage subsequently have enlarged in all surgical disciplines [9][10][11][12][13][14][15][16][17].…”

Perioperative bleeding management in pediatric patients

“…Acquired factor XIII deficiency appears prevalent even in major pediatric surgery, but no sound data exist on pediatric FXIII supplementation [25,35 & ]. Recombinant factor VIIa (rFVIIa) has been described as useful for controlling severe bleeding in cardiac [59][60][61] and neurosurgical procedures in children [62][63][64], although a prospective, randomized trial in pediatric cardiac surgery failed to prove a significant difference in blood loss following administration of rFVIIa compared to placebo [65]. Thus, there are insufficient data to make any evidencebased recommendations concerning the efficacy of rFVIIa as prophylactic, routine or rescue therapy in pediatric perioperative bleeding management [66].…”