Clotting factor activity in thawed Octaplas® LG during storage at 2-6°C for 6 days from a quality assurance point of view.

Author(s): Keller MK, Krebs M, Spies C, Wernecke KD, Heger A, von Heymann C

Publication: Transfus Apher Sci, 2012, Vol. 46, Page 129-36

PubMed ID: 22370039 PubMed Review Paper? No

Purpose of Paper

Conclusion of Paper

Studies

1. Study Purpose

   The purpose of this study was to determine the effects of storage of thawed Octaplas LG plasma at 2-6 degrees C on clotting factors and inhibitors. Octaplas LG is a filtered, solvent and detergent treated pooled plasma commercially sold for clinical use. Frozen Octaplas LG plasma was thawed for 30 min on a Plasmatherm device and shaken gently prior to sampling.

   Summary of Findings:

   After 6 days of storage, FV, FVII, FVIII, FXI and fPS levels were 15%, 19%, 19%, 13%, and 4% lower, respectively than levels measured immediately after thawing plasma (p<0.001, all). Further, after 6 days, fibrinogen levels were 7% higher and FII levels were 2% lower than levels measured immediately after thawing plasma (p=0.0135 and p=0.0231, respectively), but the authors state these changes were not significant. FIX, PC and PI were not significantly different after 6 days of storage than immediately after thawing. FII and FV levels increased by 3% (p<0.0001) and 1% (p=0.0011), respectively, and FVIII decreased by 4% (p<0.001) compared to the published values during the first 6 h of storage at 2-6 degrees C. After 24 h of storage, significant increases in FII and FIX, and decreases in FV, FVII, FVIII, FXI, fPS, and PI levels in plasma were measured compared to levels measured after 6 h of storage. Between 24 and 48 h FII, FVII, FIX, FXI and fPS levels decreased significantly, but PI remained stable during this time window. Between 48 h and 6 days, all analytes changed significantly (by 12% or less) at at least one time point.

   Biospecimens

   • Bodily Fluid - Plasma

   Preservative Types

   • Frozen

   Diagnoses:

   • Normal

   Platform:

   Analyte	Technology Platform
   Protein	Clinical chemistry/auto analyzer
   Protein	Colorimetric assay
   Protein	Immunoassay
   Protein	Hematology/ auto analyzer
   Glycoprotein	Hematology/ auto analyzer

   Pre-analytical Factors:

   Classification	Pre-analytical Factor	Value(s)
   Storage	Storage duration	0 h 2 h 4 h 6 h 1 day 2 days 3 days 4 days 5 days 6 days

   View more