Recombinant Activated Factor VII as a Hemostatic Agent in Very Low Birth Weight Preterms With Gastrointestinal Hemorrhage and Disseminated Intravascular Coagulation

Abstract

Acute hemorrhage in preterm infants leads immediately to a life-threatening event because of the small circulating blood volume. The beneficial use of recombinant activated Factor VII (rFVIIa; NovoSeven, NovoNordisk, Gentofte, Denmark) as hemostatic treatment in neonates with hemorrhagic shock has been described. Necrotizing enterocolitis is a challenge in neonatology as the disease represents one of the leading causes of mortality in preterm infants. We report on the use of rFVIIa in very low birth weight (<1500 g), preterms with intestinal hemorrhage, and disseminated intravascular coagulation (DIC). Retrospective analysis of 5 cases. Five preterm infants <or=28 weeks gestational age with DIC and hemorrhagic shock due to severe diffuse gastrointestinal bleeding. Intravenous bolus administration of 100 to 180-microg/kg rFVIIa (total of 9 doses) as rescue procedure after other interventions (substitution of platelets, fresh frozen plasma, red packed cells, surgery) failed to achieve hemostasis. Two patients with severe acidosis, hypothermia, and thrombopenia died in hemorrhagic shock, treatment with rFVIIa was unsuccessful. In 3 patients, rFVIIa was effective and gastrointestinal bleeding could be stopped. No acute adverse event, increasing bowel necrosis, increasing platelet consumption, or thromboembolic complications were observed. In this small group of preterms with DIC, intestinal hemorrhage, and persistent hemorrhagic shock, rFVIIa was effective as a rescue therapy but failed in patients with severe acidosis, hypothermia, and thrombopenia.