Cold platelets for trauma‐associated bleeding: regulatory approval, accreditation approval, and practice implementation—just the “tip of the iceberg”

Abstract

In the future, pathogen-reduced (PR), PLT additive solution (PAS) CS-PLTs seem more practical due to low risks of bacterial contamination and storage-related clotting. This should make longer storage of CS-PLTs feasible (e.g., 10 days or more). With a longer shelf life, PR PAS CS-PLTs could potentially be used in a wider range of patient populations.

An in vitro pilot study of apheresis platelets collected on Trima Accel system and stored in T‐PAS+ solution at refrigeration temperature (1‐6°C)

“…For PLT storage, PASs are composed of compounds that regulate PLT metabolism and activation, buffering PLTs to prevent the fall of pH. Extended storage of PLTs at refrigeration temperature is known to cause in‐bag PLT clumping (visible aggregates) due to activation of PLT receptors and binding to plasma fibrinogen . Cold storage of PLTs in PAS reduces receptor activation and has been shown to mitigate PLT clumping .…”

Maximising platelet availability by delaying cold storage

“…Cold storage of platelets is an attractive methodology as it ameliorates many of the issues inherent to RT storage . Studies have shown that platelet refrigeration reduces the risk of bacterial proliferation, decreases platelet metabolic activity and minimises the release of biological response modifiers (BRMs) .…”

“…Studies have shown that platelet refrigeration reduces the risk of bacterial proliferation, decreases platelet metabolic activity and minimises the release of biological response modifiers (BRMs) . Furthermore, cold storage provides the advantage of potentially extending the platelet shelf life . Importantly, studies demonstrate cold storage preserves the in vitro haemostatic potential of platelets and in vivo function .…”

Cold storage of platelets in platelet additive solution: an in vitro comparison of two Food and Drug Administration–approved collection and storage systems

“…Cold storage (1‐6°C) of PLTs for up to 3 days is currently approved by the Food and Drug Administration (FDA) for use in the resuscitation of actively bleeding patients and represents a viable alternative to RT storage. Several groups have reported superior hemostatic efficacy of cold‐stored PLTs over RT PLTs in clinical studies . Although PLTs can be cold‐stored in plasma, an increased risk of PLT clumping during storage due to activation of the glycoprotein (GP) IIb/IIIa receptor and fibrinogen binding can result in a high discard rate .…”

“…Several groups have reported superior hemostatic efficacy of cold‐stored PLTs over RT PLTs in clinical studies . Although PLTs can be cold‐stored in plasma, an increased risk of PLT clumping during storage due to activation of the glycoprotein (GP) IIb/IIIa receptor and fibrinogen binding can result in a high discard rate . Recent work from our group has shown that cold storage of PLTs in a PLT additive solution (PAS) can minimize cold PLT clumping by dilution of plasma fibrinogen while preserving PLT function for at least 15 days …”