title: Recombinant activated factor VII usage in life threatening hemorrhage: a pediatric experience.
abstract: OBJECTIVE
  To determine the safety and efficacy of off label usage of Recombinant activated factor VII (rFVIIa) in children with severe bleeding in non-hemophiliac children with diverse etiologies like leukemia, post hematopoietic stem cell transplantation, dengue shock syndrome and Glanzmann thrombasthenia.
  
  
  METHODS
  Medical records of 16 non-hemophiliac children with 20 bleeding episodes where rFVIIa was administered only after failure of standard measures to control bleeding were retrospectively reviewed and data collected regarding patient demographics, diagnosis and location of bleeding. Blood counts, coagulation and other lab parameters, both pre and post rFVIIa, were also noted. Severity of bleeding was assessed using a scoring system used previously by Nevo S et al. A record of usage of the amount of blood components (red blood cells, platelets, fresh frozen plasma, and cryoprecipitate) 24 h pre and post rFVIIa was also made. The dose of rFVIIa and any adverse side effects were recorded.
  
  
  RESULTS
  Bleeding sites were gastrointestinal (13/20), pulmonary hemorrhage (6/20) and intracranial hemorrhage (1/20). Thrombocytopenia (platelet count <50,000/cumm) was present in 50% episodes and five had refractory low platelets. Usage of packed red cells and platelets was significantly less after usage of rFVIIa (p value 0.001 and 0.006, respectively). Mean dosage of rFVIIa was 77 μgm/kg/dose (range 60 to 90 μgm/kg/dose). The bleeding stopped completely in 11(55%), decreased to minimal in 2 (10%), reduced but transfusions needed in 4 (20%) and did not stop in 3 (15%) episodes. Five patients (31%) did not survive the bleeding episode. None of the patients developed thrombosis.
  
  
  CONCLUSIONS
  rFVIIa appears to be safe and effective in controlling life-threatening bleed in non-hemophiliac children.
authors.affiliation: Pediatric Hematology Oncology & BMT Unit, Department of Pediatrics, Sir Ganga Ram Hospital, Delhi, India.
authors.forename: Sunil
authors.initials: S
authors.lastname: Bhat
authors.forename: Satya Prakash
authors.initials: SP
authors.lastname: Yadav
authors.forename: Madasu
authors.initials: M
authors.lastname: Anjan
authors.forename: Veronique
authors.initials: V
authors.lastname: Dinand
authors.forename: Anupam
authors.initials: A
authors.lastname: Sachdeva
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D004638:Emergency Treatment; D015942:Factor VIIa / Q000627:therapeutic use*; D005260:Female; D006470:Hemorrhage / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D008297:Male; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies
chemical_list: D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa