Component specification

7.5.4: Cryoprecipitate, Pooled, Leucocyte Depleted

The pooled component provides a concentrated source of FVIII, von Willebrand factor, fibrinogen, FXIII and fibronectin. It is derived from units of Fresh Frozen Plasma, Leucocyte Depleted (LD). The plasma from which the Cryoprecipitate, Pooled, LD is produced contains less than 1×106 leucocytes per primary component.

---

7.5.4.1: Technical information

• Donations of whole blood where the bleed time exceeded 15 minutes are not suitable for the production of plasma components for direct clinical use.
• Cryoprecipitate, Pooled, LD is the cryoglobulin fraction of plasma obtained by thawing and pooling five single Cryoprecipitate, LD components or pooling five single Cryoprecipitate, LD components immediately after production from thawed fresh frozen plasma.
• Plasma should be selected from male donors or consideration should be given to screening female donors for HLA/HNA antibodies, as a TRALI risk reduction measure.
• For storage, Cryoprecipitate Pooled, LD should be rapidly frozen to a core temperature of -25°C or below within 2 hours of preparation.
• Component samples collected for the quality monitoring assessment of FVIII should be from an equal mix of group O and non-O donations due to the difference in FVIII levels between ABO blood groups.
• Initial process validation must ensure that for a minimum of 20 tested Cryoprecipitate, Pooled, LD components a minimum of 75% of those components tested for the parameters shown in Table 7.5.4 shall meet the specified values.
• Annual process validation is acceptable for quality monitoring purposes, provided that the primary components, Fresh Frozen Plasma, LD and/or Cryoprecipitate, LD are separately monitored as part of monthly testing. If this is not the case, test monthly 1% or as determined by statistical process control (if ≤10 components produced per month then test every available component), of Cryoprecipitate Pooled, LD components. A minimum of 75% of those components tested for the parameters shown in Table 7.5.4 shall meet the specified values.
• A secure system must be in place to ensure a full audit trail and that the correct identification number is put on the final component pack.
• Cryoprecipitate Pooled, LD should be administered through a CE/UKCA/UKNI marked transfusion set.

---

7.5.4.2: Labelling

For general guidelines, see chapter 6.6.

The following shall be included on the label:

(* = in eye-readable and UKBTS approved barcode format)

• Cryoprecipitate, Pooled, Leucocyte Depleted* and volume
• the blood component producer’s name*
• a unique pool or batch number or the donation number of all contributing units*
• the ABO group*
• the RhD group stated as positive or negative*
• the expiry date of the frozen component*
• the temperature of storage
• the blood pack lot number*
• a warning that the component must be used within 4 hours of thawing
• the name, composition and volume of anticoagulant.

In addition, the following statements should be made:

INSTRUCTION
Always check patient/component compatibility/identity
Inspect pack and contents for signs of deterioration or damage
Risk of adverse reaction/infection, including vCJD

---

7.5.4.3: Storage

For general guidelines, see chapter 6.7.

• The component should be stored at a core temperature of -25°C or below for a maximum of 36 months.
• Although a storage temperature below -25°C improves the preservation of labile coagulation factors, lower temperatures increase the fragility of plastic. Particular care must be taken when handling such packs.
• The component should be thawed in a waterbath or other equipment designed for the purpose, within a vacuum‑sealed overwrap bag according to a validated procedure. The optimal temperature at which the component should be thawed is 37°C; temperatures between 33°C and 37°C are acceptable.
• Protocols must be in place to ensure that the equipment is regularly cleaned and maintained to minimise the risk of bacterial contamination. After thawing, the content should be inspected to ensure that no insoluble precipitate is visible and that the container is intact.
• Once thawed, the component must not be refrozen and should be transfused as soon as possible. If delay is unavoidable, the component should be stored at ambient temperature and used within 4 hours.

---

7.5.4.4: Testing

In addition to the mandatory and other tests required for blood donations described in chapter 9, and leucocyte counting (see chapter 6.3 and chapter 7.1.1), a minimum of 75% of those components tested for the parameters shown in Table 7.5.4 shall meet the specified values.

Table 7.5.4: Cryoprecipitate, Pooled, LD – additional tests

Parameter	Specification	Frequency of test
Parameter Volume	Specification 100–150 mL	Frequency of test 1% or as determined by statistical process control (if ≤10 components produced per month then test every available component)
Parameter Fibrinogen	Specification ≥700 mg/unit	Frequency of test Refer to 7.5.4.1: Technical information above
Parameter FVIII	Specification ≥350 IU/unit	Frequency of test Refer to 7.5.4.1: Technical information above
Parameter Leucocyte count (1,2)	Specification <1×106/unit in the starting component	Frequency of test As per chapter 6.3 and chapter 7.1.1

---

7.5.4.5: Transportation

For general guidelines, see chapter 6.11.

Every effort should be made to maintain the core storage temperature during transportation. Unless the component is to be thawed and used straightaway it should be transferred immediately to storage at the recommended temperature.