title: Safety of a universal, virus-inactivated and prion-depleted, pharmaceutical-quality plasma: a randomized, double-blind, clinical trial in healthy volunteers.
abstract: BACKGROUND
  Universal plasma is intended to be transfused irrespective of the blood group. We compared the safety and tolerability of a novel, universal blood group-independent plasma with an ABO-matched plasma.
  
  
  METHODS
  In this randomized, double-blind, active-controlled, crossover, Phase I trial, 30 healthy adult volunteers (blood group A, B, or AB) were randomly assigned to transfusion of 1200 mL of Uniplas LG and 1200 mL of Octaplas LG (both Octapharma AG) or vice versa. In both periods, plasmapheresis (PPh, 600 mL) preceded the infusion. Blood samples were drawn before and after PPh and 15 minutes, 2 hours, 24 hours, and 7 days after end of plasma transfusion, to assess safety and efficacy. The primary safety outcome was change in hemoglobin (Hb) concentration; secondary safety outcomes were direct antiglobulin test (DAT), complement activation, free Hb, haptoglobin, and indirect bilirubin. Efficacy was assessed by evaluation of coagulation variables.
  
  
  RESULTS
  Variations of Hb concentration were similar between treatments and within normal range; 90% confidence interval was within predefined limits of equivalence. No subject exhibited a positive DAT. All other secondary variables which could reflect hemolytic transfusion reactions (HTRs) fell within normal range; this suggests that no HTRs occurred. Most adverse events were of mild intensity; two subjects experienced dyspnea, leading to the withdrawal from the study of one subject.
  
  
  CONCLUSIONS
  Universal plasma was equivalent to ABO-matched plasma with respect to safety and tolerability. Eliminating the risk of ABO incompatibility, this universal plasma represents an advance over blood group-specific plasma.
authors.affiliation: Department of Blood Group Serology and Transfusion Medicine, Clinical Chemistry and Laboratory Diagnostics, and Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.
authors.forename: Petra
authors.initials: P
authors.lastname: Jilma-Stohlawetz
authors.forename: Friedrich W
authors.initials: FW
authors.lastname: Kursten
authors.forename: Claudia
authors.initials: C
authors.lastname: Walasek
authors.forename: Michaela
authors.initials: M
authors.lastname: Horvath
authors.forename: Gerda
authors.initials: G
authors.lastname: Leitner
authors.forename: Jana
authors.initials: J
authors.lastname: List
authors.forename: Peter
authors.initials: P
authors.lastname: Quehenberger
authors.forename: Michael
authors.initials: M
authors.lastname: Schwameis
authors.forename: Johann
authors.initials: J
authors.lastname: Bartko
authors.forename: Bernd
authors.initials: B
authors.lastname: Jilma
mesh_terms: D000017:ABO Blood-Group System; D016913:Blood Component Transfusion / Q000009:adverse effects*; D004311:Double-Blind Method; D006801:Humans; D010949:Plasma / Q000737:chemistry* / Q000821:virology*; D010956:Plasmapheresis; D038301:Virus Inactivation
chemical_list: D000017:ABO Blood-Group System