Section 8.15

8.15   Cryoprecipitate, Leucocyte Depleted

The component represents a source of concentrated FVIII:C, and von Willebrand factor, fibrinogen, Factor XIII and fibronectin from a unit of fresh frozen plasma. The plasma from which the cryoprecipitate was produced contains less than 5 x 10⁶ leucocytes per component and derived from a previously tested donor (as defined in Section 8.3).

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, Leucocyte Depleted is the cryoglobulin fraction of plasma obtained by thawing a single donation of fresh frozen plasma, Leucocyte Depleted at 4°C±2°C.

For storage, Cryoprecipitate, Leucocyte Depleted should be rapidly frozen to a core temperature of –25°C or below within two hours of preparation.

Component samples collected for the Quality Monitoring assessment of FVIII:C should have approximately the same ABO group distribution as issued components.

Cryoprecipitate, Leucocyte Depleted should be transfused through a 170–200 µm filter.

Labelling (for general guidelines see Section 7.5)

The following shall be included on the component label:

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

Cryoprecipitate, Leucocyte Depleted* and volume

the blood component producer's name*

the donation number*

the ABO group*

the RhD group stated as positive or negative*

the date of collection

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 four hours of thawing

the name, composition and volume of the 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

Storage (for general guidelines see Section 7.6)

The component should be stored at a core temperature of –25°C or below for a maximum of 24 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 – 37 °C are acceptable. Protocols must be in place to ensure that the equipment is cleaned daily and maintained to minimize the risk of bacterial contamination. After thawing, the content should be inspected to ensure that no insoluble cryoprecipitate is visible and that the container is intact.

Once thawed, the component must not be refrozen and should be used immediately. If delay is unavoidable, the component should be stored at ambient temperature and used within four hours.

Testing

In addition to the mandatory and other tests required for blood donations described in Chapter 10, and leucocyte counting (see Sections 7.2 and 8.1), a minimum of 75% of those components tested for the parameters shown in Table 8.12 shall meet the specified values.

Transportation (for general guidelines see Section 7.10)

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

*Methods validated for counting low numbers of leucocytes must be used.
**Prefreeze in starting component.