P106The evidence from the manufacture and clinical use of cryopreserved platelets in hemato-oncological and surgical patients in the Russian federation between 2016 and 2021статья
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Аннотация:Blood products - Novel blood productsP106The evidence from the manufacture and clinical use of cryopreserved platelets in hemato-oncological and surgical patients in the Russian federation between 2016 and 2021I. V. Vysochin1, T. Astrelina1, O. Kvan2, S. Smelyanets2, D. Nakhodkin3, L. Sudakova3, A. Gavriley4, G. Goncharskaya4, M. Kochetkova4, A. Zaraev5, D. Shirokov5, R. Turaev 6, L. Sibgatullina6, G. Rakhmanova6, R. Khamitov7, R. Ayupova7, E. Strelnikova7, E. Pavlova7, A. Sukhareva8, E. Vlasova8, D. Zhuravlev9, T. Nikishina9, Y. Tyurikov10, E. Seeling10, A. Orlov11, E. Kozlova11, Y. Chemakin12, T. Gorachkina12, L. Fathullina13, M. Smirnova14, L. Patrina14, I. Vafin15, S. Ragojina15, I. Ishchenko16, N. Shlikova16, D. Uzdenova17, F. Lyauzheva17, J. Ferapontova18, L. Kovalchuk18, V. Khvatov19, I. Sarkisov20, A. Sarkisov201A.I. Burnazyan Federal Medical and Biophysical Centre of Russia's Federal Medical Biological Agency, 2N. N. Burdenko National Medical Research Center of Neurosurgery of Ministry of Health of Russian Federation, Moscow, 3Regional Blood Bank, Vladimir, 4Regional Blood Bank, Tyumen, 5Udmurtia's Blood Bank, Izhevsk, 6Tatarstan's Blood Banking Centre, Kazan, 7Bashkortostan's Blood Bank, Ufa, 8Yugra's Clinical Hospital, Khanty-Mansiysk, 9Komi's Blood Bank, Syktyvkar, 10Regional Blood Bank, Ivanovo, 11Regional Blood Bank, Ekaterinburg, 12Yugra's Blood Bank, Surgut, 13Interregional Clinic and Diagnostic Center, Kazan, 14Blood Bank of Russia's Federal Medical Biological Agency, Ekaterinburg, 15Kuzbass' Blood Banking Centre, Kemerovo, 16Blood Bank, Rostov-on-Don, 17Blood Bank, Nalchik, 18Regional Blood Bank, Astrakhan, 19Sklifosovsky Research Institute for Emergency Medicine of Moscow Health Department, 20Research and Development Company BIOTEKH-M, Moscow, Russian FederationBackground: The platelet cryopreservation method and Cryotromboset™ system have been developed and patented by research and development company BIOTEKH-M in the Russian Federation (RF). The developments have been adopted for routine use by blood banks in 15 of the Russian regions since 2016. Its duality notwithstanding, the platelet cryopreservation technology has proven to be more commonly utilized in civilian medicine.Aims: We sought to assess the reproducibility and clinical efficacy of cryopreserved platelets in haematology oncology and surgical patients.Methods: Platelet concentrates (PCs) were cryopreserved using one and the same technique within 24 h of harvest by apheresis. Thawed PCs were stored and shipped at 20–24°C no longer than 6 h before transfusion. The cryopreserved PCs (CPCs) were transfused into patients to correct thrombocytopenia. Corrected count increments for platelets (CCIs) were determined at 1 and 24 h post-transfusion.Results: All the blood banking centres and blood banks collected PCs by apheresis with the use of equipment from different manufacturers. However, the quality of the PCs obtained showed no significant differences in either platelet volume or count. The volume of PCs was 250 ± 15 ml and the platelet count −255 ± 20 × 109/dose. CPCs were manufactured employing one and the same RF-patented procedure. Over 6 years, 8387 (13% of the PC collection volume) doses of CPCs have been produced in 17 health facilities, and 6661 therapeutic CPC doses have been defrosted and transfused to patients. Across all the regions, the post-thaw platelet recovery did not vary significantly and was 87 ± 5%. In eight Russian regions, half of all CPC transfusions were administered predominantly to blood cancer patients: Vladimir—74%, Izhevsk—57%, Ufa—51%, Khanty-Mansiysk—50%, Syktyvkar—45%, Ivanovo—68%, Surgut—41%, Rostov—81%. In the other regions, primarily surgical patients received CPC transfusions. In none of the hospitals were any post-transfusion adverse events seen in patients given CPC transfusions, with a 1 h CCI of over 7500 m2/μl and a 24 h CCI of at least 4500 m2/μl in the recipients' blood. Surgical bleeding in hemorrhagic thrombocytopenic patients was controlled or reduced. Hemato-oncological patients were found to have a prolonged elevation in platelet count and their clinical feature (petechial rash) disappeared.Summary/Conclusions: All of the hospitals reported CPCs to be highly effective in a clinical setting. The pronounced clinical efficacy appears to be due to the adequate CPC quality. The CCI being high at 24 h post-transfusion is suggestive of the donor platelets still circulating in the recipient's blood within 24 h.