Recombinant activated Factor VII as a hemostatic agent in very low birth weight preterms with gastrointestinal hemorrhage and disseminated intravascular coagulation.

OBJECTIVE: 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).

DESIGN: Retrospective analysis of 5 cases.

PATIENTS: Five preterm infants <or=28 weeks gestational age with DIC and hemorrhagic shock due to severe diffuse gastrointestinal bleeding.

INTERVENTION: 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.

RESULTS: 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.

CONCLUSIONS: 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.