A biochemical comparison of Octaplas with a universally applicable development product (Uniplas) and single-donor fresh-frozen plasmas subjected to methylene-blue dye and white-light treatment

Introduction

The aim of this study was to perform an extensive biochemical comparison of the pharmaceutically licensed coagulation active plasma Octaplas with an identical, but universally applicable, development product (Uniplas) and single-donor fresh-frozen plasma (FFP) units subjected to a medical device treatment using a combination of methylene-blue dye and subsequent white-light exposure (MB plasma).

Methods

Twenty-four batches of Octaplas of different blood groups and different plasma sources, three batches of Uniplas (both products manufactured by Octapharma PPGmbH, Vienna, Austria) and 20 random commercially available bags of MB plasma of different blood groups were analysed. Beyond the global coagulation parameters, the activities of coagulation factors and protease inhibitors, as well as plasminogen, activated factor VII, plasma turbidity and lipid components, were quantified.

Results

Similar to Octaplas, Uniplas showed standardised levels of coagulation factors, plasminogen and protease inhibitors (decreased protein S and antiplasmin activities) according to the product specifications. MB plasma revealed fibrinogen levels close to or below the physiological range (<1.5 mg/ml). Coagulation factor activities in single MB plasma units both below and above the normal ranges for FFP were found in this study, reflecting the considerable variability of clinically important plasma proteins. Moreover, MB plasma revealed a higher turbidity after thawing, probably due to the elevated lipid parameters.

Conclusion

This study showed that there are significant differences in the biochemical characteristics between Octaplas and MB plasma, while Uniplas revealed the same high quality as Octaplas. The variability of several plasma proteins in the 20 individual MB plasma units tested was high compared with Octaplas/Uniplas. For plasma prescribers and physicians it is also important to consider the significant loss of functional fibrinogen in MB plasma when planning and monitoring the treatment of severely ill patients.