The 34th edition of the AABB guidelines took effect in early April 2024 with expanded guidance on the storage, manufacture, and use of cold stored platelets in alignment with last year’s guidance from the FDA.
This guidance has sparked an increase in research in cold-stored platelets for other uses that may have a profound impact on the transfusion medicine industry.
In this blog, we’ll discuss the history of cold-stored platelets, updated guidance for use, and ongoing research topics.
The History of Cold-stored Platelets
Prior to last year’s guidance from the FDA, cold-stored platelets had been largely abandoned since the 1960s. Upon observing patients receiving transfusions for chronic thrombocytopenia, researchers discovered that platelets stored between 1° and 6° C were cleared from the body too quickly to deliver therapeutic benefit in patients with chronic thrombocytopenia.
In 1969, Drs. Scott Murphy and Frank Gardner demonstrated that platelets stored at room temperature could maintain hemostatic viability for up to 3 days.
This was a valuable but problematic discovery. Due to the extremely brief window of viability for platelets stored at room temperature, supply chain and wastage immediately became problems for platelet transfusion, and since platelets were stored at room temperature, they were far more likely to become contaminated with bacteria than platelets stored at refrigerated temperature.
In the subsequent 50 years, advancements were made in platelet storage, such as temperature-controlled incubation and continuous agitation, that extended the viability of platelets to between 5 and 7 days.
Advancements in medical technology continue to move the field of transfusion medicine and platelet storage forward to relieve supply chain issues and provide better access to care for patients.
The Re-emergence of Cold-Stored Platelets
In 2023, the FDA, recognizing the urgent need for platelets, released guidance that outlined alternative procedures to 21 CFR 610.53(b) and 21 CFR 606.65(e), which allowed for storage “of apheresis platelets at 1 to 6 degrees Celsius for up to 14 days from the date of collection when such apheresis platelets are intended for the treatment of active bleeding when conventional platelets are not available or their use is not practical.”
The FDA also released guidance on exceptions to the requirements in 21 CFR 640.25(b)(1) and 21 CFR 640.25(b)(3) regarding the measurement of platelets and of plasma volume, including for the manufacture “of apheresis platelets stored at 1 to 6 degrees Celsius for up to 14 days from the date of collection, and intended to treat active bleeding when conventional platelets are not available or their use is not practical.”
While the indicated use of cold-stored platelets remains narrow, the treatment of “active bleeding when conventional platelets are not available or their use is not practical.” This updated guidance represents a landmark development in the future of transfusion medicine, promising to relieve a small, but not insignificant amount of strain on platelet supply.
The Future of Platelet Research
Several other methods of platelet processing have been researched or are currently being researched including freeze dried (lyophilized) platelets for use outside the hospital and cryo-preserved platelets, both of which have the potential to extend the shelf life of platelet products from days to years.
Ongoing platelet studies include the CHIPS study, a phase 3 international study comparing the benefits of cold-stored platelets vs. room temperature platelets in posttransfusion adult and pediatric cardiac surgery patients and the CriSP-HS and CriSP-TBI studies, which are investigating the efficacy of cold-stored platelets in patients experiencing hemorrhagic shock and traumatic brain injury respectively.
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A Trusted Partner in Platelet Storage
For almost 50 years, Helmer Scientific has been designing and engineering premium products for the storage and processing of blood and blood products.
Our Pro Line Platelet Incubators and Agitators provide superior temperature control and energy efficient continuous agitation to ensure maximum viability for room-temperature platelets and our blood bank line of GX Solutions refrigerators provide superior temperature control and energy efficiency for the proper storage of whole blood and cold-stored platelets.
To request a quote for your blood bank or transfusion medicine facility, contact your local Helmer representative or visit our website today.
