title: Fresh frozen plasma prepared with amotosalen HCl (S-59) photochemical pathogen inactivation: transfusion of patients with congenital coagulation factor deficiencies.
abstract: BACKGROUND
  Photochemical treatment (PCT) with amotosalen HCl (S-59) was developed to inactivate pathogens and white blood cells in plasma (PCT-FFP) used for transfusion support.
  
  
  METHODS
  An open-label, multicenter trial was conducted in patients with congenital coagulation factor deficiencies (factors [F]I, FII, FV, FVII, FX, FXI, and FXIII and protein C) to measure the kinetics of specific coagulation factors, hemostatic efficacy, and safety of PCT-FFP. Posttransfusion prothrombin time (PT), partial thromboplastin time (PTT), and clinical hemostasis were evaluated before and after PCT-FFP transfusions.
  
  
  RESULTS
  Thirty-four patients received 107 transfusions of PCT-FFP for kinetic studies or therapeutic indications (mean dose, 12.8 +/- 8.5 mL/kg). Incremental factor recoveries ranged from 0.9 to 2.4 IU per dL per IU per kg (FII, FV, FVII, FX, FXI, and protein C). Mean pretransfusion PT (20.7 +/- 22.2 sec) corrected after PCT-FFP (13.8 +/- 2.4 sec, p < 0.001). Mean pretransfusion PTT (51.2 +/- 29.3 sec) corrected after PCT-FFP (32.0 +/- 5.1 sec, p < 0.001). Thirteen patients required 77 transfusions for therapeutic indications. PCT-FFP provided effective hemostasis and was well tolerated.
  
  
  CONCLUSIONS
  Replacement coagulation factors in PCT-FFP exhibited kinetics and therapeutic efficacy consistent with conventional FFP.
authors.affiliation: Department of Pediatric Hematology, University of Virginia, Charlottesville, Virginia, USA.
authors.forename: Pedro
authors.initials: P
authors.lastname: de Alarcon
authors.forename: Richard
authors.initials: R
authors.lastname: Benjamin
authors.forename: Marion
authors.initials: M
authors.lastname: Dugdale
authors.forename: Craig
authors.initials: C
authors.lastname: Kessler
authors.forename: Rinah
authors.initials: R
authors.lastname: Shopnick
authors.forename: Peter
authors.initials: P
authors.lastname: Smith
authors.forename: Thomas
authors.initials: T
authors.lastname: Abshire
authors.forename: Julie
authors.initials: J
authors.lastname: Hambleton
authors.forename: Prasad
authors.initials: P
authors.lastname: Matthew
authors.forename: Idith
authors.initials: I
authors.lastname: Ortiz
authors.forename: Alice
authors.initials: A
authors.lastname: Cohen
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Konkle
authors.forename: Michael
authors.initials: M
authors.lastname: Streiff
authors.forename: Martin
authors.initials: M
authors.lastname: Lee
authors.forename: David
authors.initials: D
authors.lastname: Wages
authors.forename: Laurence
authors.initials: L
authors.lastname: Corash
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001778:Blood Coagulation Disorders / Q000097:blood / Q000628:therapy*; D001779:Blood Coagulation Factors; D001793:Blood Preservation; D001803:Blood Transfusion; D002648:Child; D002675:Child, Preschool; D005260:Female; D011564:Furocoumarins / Q000494:pharmacology; D006487:Hemostasis; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D010949:Plasma; D011517:Prothrombin Time
chemical_list: D001779:Blood Coagulation Factors; D011564:Furocoumarins; C118577:amotosalen