Assessment of TRIMA plasma for reconstituting cryopreserved apheresis platelets
What was the question?
At the moment, the only option for reconstituting cryopreserved platelets for the Australian Defence Force is whole blood derived plasma. We wanted to find out whether plasma collected using the TRIMA system would be suitable for clinical use and for reconstituting cryopreserved platelets. The information from this assessment will be used to introduce an alternative
type of plasma that can be used by the ADF for reconstituting platelets and as clinical plasma.
Why is it important?
Currently, only deep frozen plasma manufactured from whole blood collections has been validated for reconstituting cryopreserved platelets. Apheresis plasma collected with the Haemonetics platform is not suitable for cryopreserved platelet reconstitution because it increases the chances of platelet aggregation. This is likely due to a lower anticoagulant ratio in the Haemonetics plasma compared to whole blood-derived plasma, and the type
of anticoagulant used (sodium citrate).
Instead, we think plasma collected on the TRIMA platform may be better suited for reconstituting cryopreserved apheresis platelets because it uses a more suitable type (ACD-A) and ratio of anticoagulant.
What did we do?
We selected two donor centres (Elizabeth Street and Liverpool) and collected 18 plasma only donations using the TRIMA Accel automated blood collection system and Multiplasma Sets. These donations werethen split into two units and processed by Manufacturing to make deep frozen plasma. We used this plasma to reconstitute frozen platelets and looked for signs of platelet aggregation and activation. We also tested the plasma for coagulation factors and compared it to whole blood derived plasma as well as apheresis plasma collected using the Haemonetics platform.
What did we find out?
The TRIMA plasma worked as expected; we saw minimal platelet aggregation and the plasma worked well for reconstituting cryopreserved platelets and contained high levels of important coagulation factors.
The plasma collected using the TRIMA system was also within Lifeblood specifications for coagulation factors, platelet count and leukocyte count.
This assessment will now form the basis for a manufacturing validation exercise that will begin in the near future.
If you would like more information, please contact Dr Denese Marks (firstname.lastname@example.org).
We would like to thank the donor centre staff and donors in all centres involved for assistance with this study.
The study would not have been possible without you.