Local researchers say a change in how blood platelets are stored could triple or even quadruple the U.S. supply available to treat life-threatening bleeding.<\/p>\n
Recently, study author Dr. Philip Spinella and his team published research in JAMA showing platelets stored cold for up to 21 days could soon become a viable option for treatment of bleeding injuries at hospitals and on the front lines of war \u2014 if the FDA finds his Defense Health Agency-funded work adequate to extend its existing 14-day regulation.<\/p>\n
\u201cThis could equate to saving 30, 40, 60,000 lives per year in the U.S.,\u201d said Spinella, a University of Pittsburgh professor of surgery and critical care medicine and the co-director of its Trauma and Transfusion Medicine Research Center.<\/p>\n
Currently, platelet units are stored predominantly at room temperature for just five to seven days before bacterial risk begins to develop. If left unused, they\u2019re discarded. Since the 1970s, blood banks and hospitals have stored the vast majority of their supply in this way because, while they have a shorter shelf life, room-\u00adtemperature-stored platelet units encourage longer-term, in-body survivability than cold-stored platelets. That notion makes room-temperature platelets better suited for prophylactic applications such as treating blood disorders and cancers, where the cells\u2019 survival duration is key.<\/p>\n
Prophylactic uses account for more than 65%<\/a> of platelet transfusions.<\/p>\n For decades, that prevailing line of thought, combined with the rigid economics of early blood banking, deemphasized the larger scope of platelet units that could potentially be kept viable through longer-lasting cold storage to treat bleeding injuries, which a USC Annenberg Center for Health Journalism study said kill around 31,000 people in the U.S. a year. For bleeding injuries in otherwise healthy people, platelet survival duration is far less important a factor, making cold storage the more efficient option.<\/p>\n \u201cThe (medical) community (in the 1970s) said, \u2018Maybe we need a dual inventory,\u2019 and the blood bankers all basically said in unison, we can\u2019t handle a dual inventory. We can only handle one temperature that we store platelets,\u201d said Spinella.<\/p>\n The study randomly tested refrigerated platelets in 1,000 pediatric and adult patients with bleeding injuries from 2021 to 2025. No drop-off in efficacy was observed with the increased duration. It also reiterated several more recent preclinical studies<\/a> that reexamined the issue over the years that contended cold-stored platelets actually are more effective<\/a> than their room-temperature<\/a> counterparts in treating bleeding injuries.<\/p>\n \u201cWe\u2019ve known (about cold-storage\u2019s use in bleeding injuries) since 1973,\u201d said Spinella. \u201cBut we had to repeat the trial to show that at the very least storing them cold after 21 days would at the very least be non-inferior to a room-temperature stored platelet.\u201d<\/p>\n Pitt says the FDA is mulling a revision of platelet-storage recommendations.<\/p>\n \u201cWe have very little doubt that the FDA will license the 21-day, but it will take time for them to officially then license it,\u201d said Spinella. \u201cI would hope within 12 months, we\u2019ll have them licensed \u2014 but that\u2019s a guess. It\u2019s about the speed of the FDA.\u201d<\/p>\n Vitalant blood bank\u2019s chief medical and scientific officer Dr. Ralph R. Vassallo said only about 1% of the blood service firm\u2019s supply is comprised of cold-storage platelets, which generally is kept for 14 days before disposal. He said that\u2019s a practice largely mirrored across major blood banks and hospitals. He also said blood bank leaders are ready to embrace a shift that will allow them to help meet the pressure of an aging donor base<\/a>.<\/p>\n \u201cThe FDA has essentially stated that (cold-stored platelets) should only be used when warm-stored platelets are not available, and we think that this study is going to help them recognize that this is an alternative \u2014 not something to be used only when you don\u2019t have other platelets available,\u201d said Vassallo.<\/p>\n