Cryoprecipitate Classification
Cryoprecipitate is a blood component, not a blood product. It is a leucodepleted plasma component derived from further processing of fresh frozen plasma (FFP), making it a fractionated blood component rather than a manufactured blood product 1.
Definition and Manufacturing Process
Cryoprecipitate is manufactured by thawing fresh frozen plasma at 4 ± 2°C, which causes high-molecular-weight plasma proteins to precipitate out 2. The precipitate is then collected and resuspended in a small volume of plasma 2. This processing method classifies it as a plasma component rather than a manufactured pharmaceutical product 1.
Key Distinguishing Features as a Blood Component:
Derived directly from donated blood: Cryoprecipitate is produced by further processing of FFP obtained through either centrifugation of whole blood donations or apheresis collection 2
Minimal processing: Unlike manufactured blood products (such as recombinant factor concentrates), cryoprecipitate undergoes only physical separation through cold precipitation, not chemical synthesis or extensive purification 3, 4
Pooled donor product: In the UK, it is mainly available as pooled bags of five units from multiple donors, similar to other blood components 1
Storage requirements: It is stored at -25°C and, once thawed, can be kept at ambient temperature for only 4 hours without refrigeration, consistent with blood component handling 1, 2
Composition
Cryoprecipitate contains concentrated factor VIII, von Willebrand factor, fibrinogen, factor XIII, and fibronectin 1, 3. Each single unit contains 400-450 mg of fibrinogen, and pools of five units contain at least 2 g 1, 2.
Clinical Context
While manufactured fibrinogen concentrates (true blood products) are now available as alternatives, cryoprecipitate remains classified as a blood component due to its direct derivation from donated plasma with minimal processing 5, 6. The availability of recombinant and highly purified factor concentrates has superseded cryoprecipitate use for hemophilia A and von Willebrand disease, but it remains the primary blood component for fibrinogen replacement in many settings 3, 7.