title: Quality of frozen transfusable plasma prepared from whole blood donations in Canada: an update.
abstract: BACKGROUND
  Transfusable plasma is obtained by processing whole blood donations, by apheresis, or as solvent/detergent plasma (SD plasma), a pooled pathogen-reduced plasma product. The quality of plasma is typically assessed by testing the activities of multiple coagulation-related plasma proteins, due to a lack of clinical trial data linking plasma composition to clinical endpoints. We sought to update previous quality surveys of Canadian frozen plasma (FP; manufactured from single donor whole blood donation and frozen within 24h of phlebotomy), to provide transfusionists with a more complete picture of its characteristics.
  
  
  METHODS
  FP units (n=131) were tested for: the activity of factors V, VII, VIII, X, and XI, protein S (PS), α2-antiplasmin (AP), and fibrinogen; and the activated partial thromboplastin (APTT) and prothrombin (PT) times. Comparisons were made to: previous Canadian FP surveys; and to studies of single-donor plasma and SD plasma from other nations.
  
  
  RESULTS
  Mean FVIII, fibrinogen, or APTT values did not differ from the previous annual survey of Canadian FP; FV activity was increased and PT values decreased. FP produced with or without leukoreduction differed only in mean APTT. Canadian FP exhibited generally similar quality to that reported by other organizations in Europe and Asia for similarly manufactured single-donor plasma, but contained notably higher PS and AP (≈ four-fold) activities than did SD plasma.
  
  
  CONCLUSIONS
  Our results indicate that Canadian FP is of similar quality to single-donor products produced in other jurisdictions. While it is of arguably superior in vitro quality to an SD plasma product recently licensed in Canada, these differences are highly unlikely to have clinical significance for most indications for plasma transfusion.
authors.affiliation: Canadian Blood Services Research and Development, Hamilton, Ontario, Canada; Quality Monitoring Program, Ottawa, Ontario, Canada; Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada. Electronic address: sheffiel@mcmaster.ca.
authors.forename: William P
authors.initials: WP
authors.lastname: Sheffield
authors.forename: Varsha
authors.initials: V
authors.lastname: Bhakta
authors.forename: Kimberley
authors.initials: K
authors.lastname: Talbot
authors.forename: Edward L G
authors.initials: EL
authors.lastname: Pryzdial
authors.forename: Craig
authors.initials: C
authors.lastname: Jenkins
mesh_terms: D016913:Blood Component Transfusion / Q000379:methods*; D001782:Blood Donors; D001793:Blood Preservation / Q000379:methods*; D002170:Canada; D005260:Female; D005615:Freezing; D006801:Humans; D008297:Male; D010949:Plasma
keywords: Coagulation; Hemostasis; Plasma; Plasma quality; Solvent/detergent plasma