title: A prospective trial assessing the safety and efficacy of collecting up to 840 mL of plasma in conjunction with saline infusion during plasmapheresis.
abstract: BACKGROUND
  The demand for plasma for manufacturing intravenous immunoglobulin and other plasma derivatives is increasing. A prospective study was conducted to determine whether up to 840 mL of plasma could be safely and effectively collected in conjunction with saline infusion during plasmapheresis.
  
  
  METHODS
  Ninety-one plasma donors were enrolled in a modified 3 × 3 crossover study to assess the equivalence of three plasma collection methods: 750 mL of plasma with no saline (control, Method 1), 840 mL of plasma with a 250-mL saline infusion during and at the end of the donation (Method 2), and 800 mL of plasma with a 500-mL saline infusion at the end of the donation (Method 3). The primary efficacy endpoint was the total protein concentration of the collected plasma. Secondary efficacy endpoints were immunoglobulin (Ig)G and Factor (F)VIII plasma concentration and donors' acceptance of the new procedures. Safety was determined from the adverse event (AE) rate.
  
  
  RESULTS
  The total protein, IgG, and FVIII concentrations in plasma collected under Methods 2 and 3 were significantly lower than those in plasma collected under Method 1 (p < 0.0001). These variables were also significantly lower in plasma collected under Method 2 compared to Method 3. During the study, 75 AEs were recorded, 73 of which were mild to moderate. Significantly more donors (31%) preferred Method 2 compared to Method 3 (p = 0.006).
  
  
  CONCLUSIONS
  Saline infusion during plasmapheresis led to hemodilution of plasma proteins. However, the benefits to donor safety and satisfaction are compelling reasons to implement saline infusion during plasmapheresis.
authors.affiliation: Research and Development, Australian Red Cross Blood Service, Alexandria, New South Wales, Australia.
authors.forename: Mark
authors.initials: M
authors.lastname: Buzza
authors.forename: Denese C
authors.initials: DC
authors.lastname: Marks
authors.forename: Hugh
authors.initials: H
authors.lastname: Capper
authors.forename: Elisa
authors.initials: E
authors.lastname: Cassin
authors.forename: Caro-Anne
authors.initials: CA
authors.lastname: Badcock
authors.forename: Samantha
authors.initials: S
authors.lastname: Reid
authors.forename: Matthew
authors.initials: M
authors.lastname: Kwok
authors.forename: Hung
authors.initials: H
authors.lastname: Yang
authors.forename: June
authors.initials: J
authors.lastname: Lee
authors.forename: Carolyn
authors.initials: C
authors.lastname: Corrigan
authors.forename: Tanja
authors.initials: T
authors.lastname: Hartkopf-Theis
authors.forename: Anthony
authors.initials: A
authors.lastname: Keller
mesh_terms: D000328:Adult; D000368:Aged; D000094902:Blood Banking / Q000379:methods*; D001782:Blood Donors; D001798:Blood Proteins / Q000378:metabolism; D001810:Blood Volume; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D007262:Infusions, Intravenous / Q000379:methods*; D008297:Male; D008875:Middle Aged; D010956:Plasmapheresis / Q000009:adverse effects / Q000379:methods* / Q000592:standards*; D011446:Prospective Studies; D012965:Sodium Chloride / Q000008:administration & dosage*; D011795:Surveys and Questionnaires
chemical_list: D001798:Blood Proteins; D007074:Immunoglobulin G; D012965:Sodium Chloride