Cryoprecipitate and cryodepleted plasma - a change is coming
Lifeblood is transitioning to split apheresis cryoprecipitate and cryodepleted plasma components - effective January 2025.
You may have heard there are significant changes coming for cryoprecipitate and cryodepleted plasma in the new year.
Due to the market withdrawal of a crucial consumable, and the lack of a compatible alternative, Lifeblood is unable to sustain the manufacture of the current large dose apheresis and cryodepleted plasma components. These will no longer be produced after 31 December 2024, when the final stock of the pack system used for the current process expires.
Although we’ll continue to collect plasma by apheresis, during processing the single plasma donation will now be split into three individual units.
What’s changing?
The National Blood Authority (NBA) and Therapeutic Goods Administration (TGA) have approved the introduction of split apheresis cryoprecipitate and cryodepleted plasma components to replace the current large dose apheresis-derived presentation.
What does this mean for cryoprecipitate dosing?
| 1 split cryoprecipitate unit will be equivalent to 1 whole blood (WB) derived unit. |
| The recommended adult dose requires the same number of units of either presentation. |
For cryoprecipitate (and cryodepleted plasma), the specifications for 1 split apheresis unit will be equivalent to 1 whole blood (WB) derived unit, as shown in the tables below. For therapeutic treatment, whole blood derived and the new split apheresis cryoprecipitate (available in 2025) are considered equivalent and interchangeable.
Both whole blood and split apheresis cryoprecipitate will be packaged and supplied as lots of three units. At the present time, the recommended adult dose is 10 units of either whole blood or split apheresis cryoprecipitate. The adult dose for the current large (unsplit) apheresis cryoprecipitate is 4 units.
Blood component specifications for cryoprecipitate
Lifeblood has also approached the NBA and The Australian & New Zealand Society of Blood Transfusion (ANZSBT) with a proposed revision to the recommended number of cryoprecipitate units necessary to achieve the adult replacement dose of fibrinogen.
| Specification | WB cryo | Split APH cryo | APH cryo (large) |
| Volume (mL) | 30 - 40 | 60 ± 10% | |
| Factor VIIIc (IU/mL) | ≥ 70 | ||
| Fibrinogen (mg/unit) | ≥ 140 | ||
| Von Willebrand Factor (IU/unit) | > 100 | ||
| Standard adult dose | 10 | 4 | |
Blood component specifications for cryodepleted plasma (CDP)
| Specification | WB CDP | Split APH CDP | APH CDP (large) |
| Volume (mL) | 240 ± 10% | 750 ± 10% | |
Lifeblood has also approached the NBA and The Australian & New Zealand Society of Blood Transfusion (ANZSBT) with a proposed revision to the recommended number of cryoprecipitate units necessary to achieve the adult replacement dose of fibrinogen.
Lifeblood’s QC data shows our cryoprecipitate consistently exceeds the specification of ≥ 40 mg/unit. This means 3 units of the current (unsplit) apheresis cryoprecipitate (until stocks are exhausted), or 9 units of whole blood derived, or 9 units of the new split apheresis cryoprecipitate (in 2025) will be sufficient to provide the adult dose of 3 to 4 g of fibrinogen. The decision on this proposed change is pending and Lifeblood will announce the outcome in due course. We will start to supply split apheresis cryoprecipitate in January, with large dose cryoprecipitate remaining available until our stocks are exhausted in early 2025.
To prepare for the upcoming changes, transfusion laboratories will need to ensure that their laboratory information (LIS) is updated to accommodate the new product which will have new component names and component codes along with their associated ISBT128/CODABAR barcodes. The laboratory will also need to prepare to manage a dual inventory of large dose and split apheresis components throughout 2025, acknowledging the 12-month shelf life of existing products manufactured in 2024.
If you require any further information, please reach out to your hospital transfusion laboratory or alternatively contact your local Lifeblood Transfusion Scientist.
