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Recovery, safety, and tolerability of a solvent/detergent-treated and prion-safeguarded transfusion plasma in a randomized, crossover, clinical trial in healthy volunteers.
MedLine Citation:
PMID:  23320451     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
BACKGROUND: Octaplas LG is a prion-depleted version of a previous generation product called Octaplas S/D. We compared the recovery, safety, and tolerability of these two pharmaceutical-grade plasmas. STUDY DESIGN AND METHODS: In this comparative, block-randomized, open-label, active-controlled, crossover Phase I trial, 60 healthy adult volunteers received single transfusions of 1200 mL of parent product (in Period 1) and of the LG plasma product (in Period 2) or vice versa. In both periods, plasmapheresis (600 mL) preceded the transfusion. Blood samples were drawn before and after apheresis and 15 minutes, 2 hours, 24 hours, and 7 days after end of plasma transfusion, to assess recovery, safety, and tolerability. The primary efficacy endpoints were the changes in coagulation factors and hemostatic variables compared to baseline; their relative recovery was computed in the per-protocol analysis (n = 43). Safety and tolerability were assessed (n = 60). RESULTS: Variations in coagulation factors and hemostatic variables over time were similar between the two treatments and within normal range; 90% confidence intervals for the derived recovery data were within predefined limits of equivalence. Both products were well tolerated. The advanced manufacturing process also significantly increased plasmin inhibitor concentrations after transfusion in vivo. CONCLUSION: The LG plasma product was bioequivalent to its predecessor with respect to recovery of clotting factors and demonstrated comparable safety and tolerability in healthy volunteers. Both products compensated well for the loss of clotting factors after apheresis (NCT01063595).
Authors:
Petra Jilma-Stohlawetz; Friedrich W Kursten; Michaela Horvath; Gerda Leitner; Jana List; Jana Marcek; Peter Quehenberger; Michael Schwameis; Johann Bartko; Ulla Derhaschnig; Bernd Jilma
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-1-16
Journal Detail:
Title:  Transfusion     Volume:  -     ISSN:  1537-2995     ISO Abbreviation:  Transfusion     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-1-16     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0417360     Medline TA:  Transfusion     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2013 American Association of Blood Banks.
Affiliation:
Department of Blood Group Serology and Transfusion Medicine, Laboratory Medicine, Medical University of Vienna, Vienna, Austria; Department of Emergency Medicine, and Clinical Pharmacology, Medical University of Vienna, Vienna, Austria; Clinical Research and Development Department, Octapharma Pharmazeutika Produktionsges.m.b.H, Vienna, Austria.
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