Coagulopathy is an important cause of mortality in
critically ill children. Traditional
therapies to correct coagulopathy lead to great time delays and cause fluid overload in patients. The authors report the effectiveness and safety of the activated recombinant
factor VII (
rFVIIa) administration in a series of 13 nonhemophiliac children with acute, life-threatening
bleeding. In this retrospective study, the records of the patients who were not diagnosed with congenital
hemorrhagic disorder and were administered
rFVIIa due to any other reason in Ege University Faculty of Medicine, Department of Pediatrics, between February 2002 and February 2007 were reviewed retrospectively. Thirteen nonhemophiliac patients with acute life-threatening
bleeding and ages ranging from 2 days to 15 years received
rFVIIa over a 5-year period. Three patients were diagnosed with hemaphagocytic lymphohistiocytosis, 4 with prematurity,
sepsis, and
disseminated intravascular coagulation (
DIC), 5 with
sepsis,
multiple organ dysfunction syndrome, and
DIC, and 1 with
acute liver failure. Severe
bleeding resulted from pulmonary (n = 3), lower gastrointestinal system (n = 2), esophagus
varices (n = 1), pulmonary and gastrointestinal system (n = 4), pulmonary, gastrointestinal system, and
intracranial hemorrhage (n = 1), and gastrointestinal system and
intracranial hemorrhage (n = 2). Median frequency of
rFVIIa administration was 3 per patient (range 2-15) and median dose of
rFVIIa was 90 microg/kg, ranging from 60 to 135 microg/kg each administration. All of the patients were given fresh frozen plasma and if necessary
platelet transfusion (n = 10) or
fibrinogen concentrate (n = 3) before administration of
rFVIIa. In 6 patients, lack of success to control
bleeding by conventional methods was the only cause to start
rFVIIa. In 7 patients, the need for volume restriction was also a significant contributing factor in deciding to start
rFVIIa. Median PT was 32.9 s (range: 19-65) before
rFVIIa administration and it was decreased to 11.6 s (range: 10.7-12.8), 2-3 h after
rFVIIa infusion.
Bleeding was stopped completely in 10 patients at least for 24 h and decreased in 3 patients 30-45 min after
rFVIIa administration. Two patients had thrombotic complications attributed to
rFVIIa administration. No other complication was observed in the other patients. In this retrospective study,
rFVIIa was found to be effective at controlling severe hemorrhagic symptoms of different etiologies in children without congenital
hemorrhagic disorder. In addition to the rapid control of
bleeding, administration of this agent improved fluid balance and led to a reduction in blood product requirements in
critically ill children. However, survival was still poor (23%), and 2/13 (15.4%) patients developed venous and arterial
thrombosis within 3 h of treatment. The authors emphasize that in acquired, acute life-threatening
bleeding, simultaneous administration of
rFVIIa with conventional treatment may contribute to patient survival. However, the risk of
thromboembolism should be considered before this treatment is given.