Collection Process of Cryoprecipitate
Cryoprecipitate is manufactured by thawing fresh frozen plasma (FFP) at 4 ± 2°C, which precipitates out factor VIII, factor XIII, von Willebrand factor, fibronectin, and fibrinogen. 1
Collection and Processing Steps
- Cryoprecipitate is a concentrate of high-molecular-weight plasma proteins that precipitate when frozen plasma is slowly thawed at 1-6°C 2, 3
- The process begins with obtaining fresh frozen plasma through either:
- The collected plasma is initially leukodepleted to reduce adverse reactions 1
- The plasma is then frozen and stored at temperatures below -25°C 1
- To create cryoprecipitate, the frozen plasma undergoes controlled thawing at 1-6°C 3, 4
- During this slow thawing process, high-molecular-weight proteins precipitate out of solution 4
- The precipitated proteins are separated through centrifugation (typically completed after 5 minutes at 1,500 g) 5
- The precipitate is then collected and resuspended in a small volume (10-20 ml) of plasma 1
Storage and Handling
- Cryoprecipitate is stored at core temperatures below -25°C for up to 36 months 1
- Once thawed for administration, it can be kept at ambient temperature for 4 hours and should not be refrigerated again 1
- If there is a delay in transfusion, cryoprecipitate can be stored at ambient temperature but must be used within 4 hours 1
- The typical infusion rate is 10-20 ml·kg⁻¹·h⁻¹ (30-60 minutes for one pool) 1
Quality Control and Content
- Each single unit of cryoprecipitate contains approximately 400-450 mg of fibrinogen 1
- Pools of five units contain at least 2 g of fibrinogen 1
- According to quality standards, 75% of packs should contain at least 140 mg of fibrinogen; pooled cryoprecipitate (from five donations) should contain > 700 mg 1
- In addition to fibrinogen, cryoprecipitate contains concentrated factor VIII, von Willebrand factor, factor XIII, and fibronectin 3, 4
Special Considerations
- For patients born in 1996 or later in the UK, cryoprecipitate is made from FFP sourced outside the UK and undergoes viral inactivation with methylene blue 1
- These components are available as single units for smaller children and pooled units for older children and young adults 1
- Rapid thawing of plasma results in higher yields of factor VIII procoagulant activity and a higher specific activity in the resulting cryoprecipitate 5
- Evidence suggests that cryoprecipitate prepared from plasma from blood stored for 24 hours may have equal or greater levels of coagulation factors compared to standard cryoprecipitate 6