title: Successful use of recombinant activated FVII and aminocaproic acid in four neonates with life-threatening hemorrhage.
abstract: Reports on the use of recombinant activated factor VII (rFVIIa) to counteract hemorrhagic shock in neonates and preterm infants are increasing. rFVIIa enhances thrombin generation in situations with impaired thrombin formation and, since thrombin has a crucial role in providing hemostasis, rFVIIa is regarded as a general hemostasis agent. Full thrombin generation is necessary for the formation of a stable fibrin plug resistant to premature fibrinolysis. Antifibrinolytic drugs are not recommended for the treatment of acute bleeding. We report four neonates (one with massive postsurgical hemorrhage after ileostomy and three with severe pulmonary hemorrhage in the course of mechanical ventilation for meconium aspiration syndrome, congenital heart disease and during postoperative resuscitation after cardiac surgery for congenital heart disease) who were successfully treated with multiple administration of rFVIIa (120 microg/kg per dose) and antifibrinolytic therapy - aminocaproic acid (100 mg/kg per dose). In a fibrinolytic environment therapeutic concentrations of rFVIIa may sometimes be insufficient to produce adequate amounts of thrombin necessary for stable clot structure. Laboratory data in three of our patients with pulmonary hemorrhage (low fibrinogen levels with slightly prolonged prothrombin time) supported this thesis, so we blocked fibrinolysis with aminocaproic acid and achieved a complete clinical and laboratory therapeutic effect.
authors.affiliation: Department of Pediatrics, University Hospital Rebro, Zagreb, Croatia.
authors.forename: Ruza
authors.initials: R
authors.lastname: Grizelj
authors.forename: Jurica
authors.initials: J
authors.lastname: Vuković
authors.forename: Boris
authors.initials: B
authors.lastname: Filipović-Grcić
authors.forename: Dalibor
authors.initials: D
authors.lastname: Sarić
authors.forename: Tomislav
authors.initials: T
authors.lastname: Luetić
mesh_terms: D015119:Aminocaproic Acid / Q000627:therapeutic use*; D000933:Antifibrinolytic Agents / Q000627:therapeutic use*; D005167:Factor VII / Q000627:therapeutic use*; D015942:Factor VIIa; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D007231:Infant, Newborn; D019106:Postoperative Hemorrhage / Q000517:prevention & control; D011994:Recombinant Proteins / Q000627:therapeutic use
chemical_list: D000933:Antifibrinolytic Agents; D011994:Recombinant Proteins; D005167:Factor VII; C103587:recombinant FVIIa; D015942:Factor VIIa; D015119:Aminocaproic Acid