The use of recombinant activated factor VII in the treatment of massive pulmonary hemorrhage in a preterm infant

Abstract

Pulmonary hemorrhage is a rare but well-known complication in preterm infants. We present a case of massive pulmonary hemorrhage in a 9-day-old male infant, successfully treated with intravenous recombinant activated factor VII (rFVIIa) (NovoSeven; Novo Nordisk). The infant was diagnosed with sepsis-related disseminated intravascular coagulation and required ventilator support for respiratory distress syndrome and blood transfusions due to active bleeding from endotracheal tube. After administration of the second dose of rFVIIa (120 microg/kg per dose, every 2 h), the active bleeding subsided dramatically and a significant improvement in the oxygenation index was seen 8 h after the third dose of rFVIIa treatment. There were also significant improvements in the prothrombin time, International Normalized Ratio, activated partial thromboplastin time and plasma fibrinogen levels after the third dose of rFVIIa treatment. The infant was discharged on day 82 of life and there was no finding of thrombosis during the hospitalization period. At month 18 of follow-up, there was no morbidity related to the pulmonary and central nervous systems. This case suggests that rFVIIa is effective as an alternative therapy in controlling massive pulmonary hemorrhage of preterm infants.

Recombinant activated factor VIIa treatment for refractory hemorrhage in infants

“…The indications for use of rFVIIa in this cohort are similar to the ones previously reported: pulmonary hemorrhage, gastrointestinal hemorrhage, NEC, subgaleal hemorrhage, subdural hematoma and post-surgical hemorrhage16–26. The overall rate of hemostasis in our cohort (72%) is comparable to that of these published reports for infants of varying age groups.…”

“…Hemostasis was achieved in all of the infants with pulmonary hemorrhage (5/5), ranging in gestational age from 24 to 32 weeks, after 1–3 doses of 90 mcg/kg of rFVIIa. Two case reports have described the successful use of rFVIIa for treatment of preterm infants with pulmonary hemorrhage, Cetin et al reported on a single case and Olomu on 2 infants, using doses of 50–120 mcg/kg16,17.…”

Off-Label Use of Recombinant Factor VIIa in Pediatric Patients

“…1 There has been an increasing number of reports of the use of rFVIIa to manage uncontrolled hemorrhage in clinical settings outside of these licensed indications, including cardiac surgery, trauma, and obstetrics. [2][3][4] Until recently, there have been few data on off-label use of rFVIIa in pediatric patients, and most have been limited to single case reports [5][6][7] and small or single-center case series, 8,9 including in cardiac surgery, [10][11][12] trauma, 13 and neurosurgery. [14][15][16] There are important differences between pediatric and adult patients with regard to their coagulation system and risk of thromboembolism, susceptibility to bleeding after cardiopulmonary bypass, 17 and the pharmacokinetics of rFVIIa.…”

Recombinant activated factor VII use in critically ill infants with active hemorrhage

“…However, in recent years, off-label rFVIIa use has been increasing in nonhemophilic patients for cessation of hemorrhage [3][4][5][6][7][8][9][10]. Reports of its use in critically ill infants are mostly limited to case reports and small case series [5][6][7][8][9][10]. We performed a large single institutional retrospective review of rFVIIa use in critically ill infants focusing on the safety and efficacy of rFVIIa.…”