With the introduction of cold-stored platelets (CSP) into practice, transfusion services have encountered challenges in interpreting FDA guidance. The FDA indicates that CSP may be used to treat active bleeding when conventional platelets—room temperature platelets (RTP)—are unavailable or impractical to use.1 In addition, the FDA requires transfusion services to develop standard operating procedures (SOPs) that define, within their own settings, the circumstances under which RTP are not available or not practical.
A recent article by Cohn et al., co-authored by Dr Pampee Young of the American Red Cross, examines seven clinical scenarios illustrating how different institutions are incorporating CSP into their transfusion practices.³
Scenario 1 – Divided campus
At a large hospital, the oncology service is about a mile from the emergency department (ED) and operating rooms (OR). The oncology service transfuses RTP. The OR/ED area has 1-6o C blood storage refrigerators. It maintains 1 RTP unit and switches to CSP when that unit is used, as obtaining additional RTP is not practical.
Scenario 2 – Rural location
Four small hospitals and one tertiary care center are within a 10-hour drive from the blood supplier. Each small hospital stocks a CSP unit which rotates to the center near the expiration date. The center’s SOP allows transfusion of CSP to actively bleeding patients. The center may use CSP if RTP are not available or if using RTP would drop its inventory below its minimum requirement.
Scenario 3 – Emergency department refrigerator
A Level II trauma center with a large oncology service stocks CSP in its ED refrigerator. RTP may also be sent by the blood bank if chosen by the clinician as this choice is considered scope of practice by the hospital. This case would not meet FDA criteria as scope of practice is not adequate justification for the use of CSP.
Scenario 4 – Frequent shortages
A hospital maintaining a dual platelet inventory experiences frequent shortages. Per SOP, CSP may be transfused to actively bleeding patients if the RTP inventory falls below a periodic automatic replenishment (PAR) level of 20. The hospital defines RTP < 20 as a state in which RTP are not available or their use is not practical, which illustrates how each hospital may make this definition based on its individual ability to obtain additional RTP.
Scenario 5 – Scope of practice and using Investigational New Drug (IND) platelets
A large institution with active transplant, cardiothoracic surgery, and oncology services is participating in CHIPS (the CHilled Platelet Study) for which it receives CSP. It routinely uses about 40 platelet units each day and plans to use the CSP only if RTP inventory is at or below about 2 units. This practice is not appropriate as the institutions’ CSP should only be used for patients enrolled in the study.4
Scenario 6 – Centralized transfusion service
A hospital is one of several served by a centralized transfusion service many miles away. It receives emergency RTP which must be rotated every 2 days to avoid expiration. This process is often impacted by staffing shortages. The hospital plans to stock 50% CSP to be used in bleeding emergencies. CSP not transfused by days 9-11 may be rotated to a tertiary care center. This practice, if documented in SOPs, is a reasonable approach for this hospital.
Scenario 7 – Emergency readiness
A large hospital’s SOP says to order CSP before a major event (e.g., a hurricane or large gathering) to ensure a robust platelet inventory. This is acceptable as long as the hospital’s SOP defines the emergency scenario use of CSP and RTP.
In summary, RTP are the current standard of care. As each hospital decides if and how to implement CSP, FDA guidance should be followed. The authors suggest asking whether RTP are available in a specific setting and whether their use is practical in that setting. If the answer to either question is no, CSP may be used, but an SOP must define that setting. The SOP should consider elements such as distance from a blood center, inventory limitations, split campuses, the hospital’s usage rate, and clinical situations in defining when CSP may be used. The advantages, disadvantages, and clinical use of CSP are further discussed in a recent PLUS article, https://redcrossplus.blog/2024/03/04/cold-stored-platelets/.
References
1. U. S. Food and Drug Administration. (2023). Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical: Guidance for Industry. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/alternative-procedures-manufacture-cold-stored-platelets-intended-treatment-active-bleeding-when. Cited 2025 Aug 19.
2. Ask the FDA and CMS/CLIA. https://www.aabb.org/docs/default-source/default-document-library/regulatory/2024-ask-the-fda-and-clia-transcript.pdf?sfvrsn=550adbd0_3. Cited 2025 Aug 19.
3.Cohn CS, Dunbar NM, Kaplan A, Spinella PC, Young PP, Ziman A. How do we maintain a dual inventory of room temperature stored platelets with cold-stored platelets? Transfusion. 2025;65(7):1218–22. https:// doi.org/10.1111/trf.18289.
4.Zantek ND, Steiner ME, VanBuren JM, Lewis RJ, Berry NS, Viele K, et al. Design and logistical considerations for the randomized adaptive non-inferiority storage-duration-ranging CHIlled Platelet Study. Clin Trials. 2023;20(1):36–46. https://doi.org/10.1177/17407745221126423.
