title: Recombinant factor VIIa (NovoSeven) as a hemostatic agent after surgery for congenital heart disease.
abstract: BACKGROUND
  Postoperative bleeding and blood product requirements can be substantial in children undergoing open-heart surgery, and reexploration is required in 1% of cases. Recombinant activated factor VII (rFVIIa, NovoSeven, NovoNordisk, Denmark) is a hemostatic agent approved for the treatment of hemophilic patients with inhibitors to factor VIII or factor IX. It has also been used with success in other conditions. We present our experience with rFVIIa treatment for uncontrolled bleeding after open-heart surgery in five pediatric patients.
  
  
  METHODS
  The study group consisted of five patients after open-heart surgery with excessive blood loss. The patients were treated with rFVIIa after failure of conventional treatment to control the bleeding. Blood loss, blood product consumption, and coagulation test results were recorded before and after rFVIIa administration.
  
  
  RESULTS
  In all cases, blood loss decreased considerably after rFVIIa administration (mean 7.8 ml x kg(-1) x h(-1)), almost eliminating the need for additional blood products, and the prolonged prothrombin time normalized. In two patients with thrombocytopathy, rFVIIa helped to discriminate surgical bleeding from bleeding caused by a defect in hemostasis. No side effects of rFVIIa treatment were noted.
  
  
  CONCLUSIONS
  These cases support the impression that RFVIIa is efficient and safe in correcting hemostasis in children after cardiopulmonary bypass when other means fail. However, the data are still limited, and more extensive research is needed.
authors.affiliation: Cardiac Intensive Care Unit, Schneider Children's Medical Center of Israel, Petah Tikva, Tel Aviv, Israel. yaronraz@clalit.org.il
authors.forename: Yaron
authors.initials: Y
authors.lastname: Razon
authors.forename: Eldad
authors.initials: E
authors.lastname: Erez
authors.forename: Bernardo
authors.initials: B
authors.lastname: Vidne
authors.forename: Einat
authors.initials: E
authors.lastname: Birk
authors.forename: Jacob
authors.initials: J
authors.lastname: Katz
authors.forename: Hanna
authors.initials: H
authors.lastname: Tamari
authors.forename: Ovadia
authors.initials: O
authors.lastname: Dagan
mesh_terms: D000293:Adolescent; D000328:Adult; D001780:Blood Coagulation Tests; D016063:Blood Loss, Surgical; D001791:Blood Platelet Disorders / Q000097:blood; D001803:Blood Transfusion; D006348:Cardiac Surgical Procedures; D002315:Cardiopulmonary Bypass; D015942:Factor VIIa / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006330:Heart Defects, Congenital / Q000601:surgery*; D006490:Hemostatics / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D019106:Postoperative Hemorrhage / Q000097:blood / Q000188:drug therapy*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012189:Retrospective Studies
chemical_list: D006490:Hemostatics; D011994:Recombinant Proteins; D015942:Factor VIIa