Recombinant factor Vila in preterm neonates with prolonged prothrombin time

The purpose of the study was to estimate the effects of a minimal and a normal dose of rFVIIa on prothrombin time, and to compare it to the effect of a standard volume of fresh frozen plasma. Recombinant factor Vila (rFVIIa) was tested in babies with gestational age less than 33 weeks and prothrombin time greater than 48 s (reference 23.7 s; i.e. inclusion at international normalized ratio > 2.0) during the first 7 days of life. Firstly, 5 mug/kg rFVIIa was given to five babies. One hour after the bolus, prothrombin time had significantly shortened from a mean of 64 s (range 53-79 s) to 46 s (range 39-56 s). Next the effect of 80 kg rFVIIa was compared to the effect of 10 mL/kg fresh frozen plasma. Prothrombin time at inclusion was 68 s (range 53-92 s). One hour after treatment prothrombin time was 33 s (range 21-42 s) in the six babies given rFVIIa, compared with 51 s (range 40-59 s) in four babies given fresh frozen plasma (P = 0.02). Prothrombin time remained lower in the rFVIIa group (P = 0.01) at 3 h than in the frozen plasma group, whereas at 6 and 12 h the differences were statistically insignificant One baby continued to have slight bleeding from the umbilical site and one baby developed severe pulmonary haemorrhage in spite of rFVIIa treatment. In conclusion, rFVIIa partially normalized prothrombin time in preterm babies. There was no evidence of side effects. Future randomized studies are needed to evaluate the haemostatic effect. (C) 2003 Lippincott Williams Wilkins.