A randomized cross-over study of cryopreserved platelets in prophylactic transfusions of thrombocytopenic patients.
bone
cryopreserved
platelets
prophylactic
subjects
thrombocytopenic
Journal
Transfusion
ISSN: 1537-2995
Titre abrégé: Transfusion
Pays: United States
ID NLM: 0417360
Informations de publication
Date de publication:
09 2023
09 2023
Historique:
revised:
06
07
2023
received:
21
04
2023
accepted:
08
07
2023
medline:
14
9
2023
pubmed:
19
8
2023
entrez:
19
8
2023
Statut:
ppublish
Résumé
The short shelf-life of liquid-stored platelets (LP) at 20-24°C poses shortage and wastage challenges. Cryopreserved platelets have significantly extended shelf-life, and were safe and efficacious for therapeutic transfusions of bleeding patients in the Afghanistan conflict and phase 2 randomized studies. Although hematology patients account for half of platelets demand, there is no randomized study on prophylactic cryopreserved platelet transfusions in them. We performed a phase 1b/2a randomized cross-over study comparing the safety and efficacy of cryopreserved buffy coat-derived pooled platelets (CP) to LP in the prophylactic transfusions of thrombocytopenic hematology patients. A total of 18 adults were randomly assigned 1:1 to CP and LP for their first thrombocytopenic period (TP) of up to 28-days. A total of 14 crossed over to the other platelet-arm for the second TP. Overall, 17 subjects received 51 CP and 15 received 52 LP. CP-arm had more treatment emergent adverse event (29.4% vs. 13.3% of subjects, 9.8% vs. 3.8% of transfusions) than LP-arm but all were mild. No thromboembolism was observed. Both arms had similar bleeding rates (23.5% vs. 26.7% of subjects) which were all mild. Subjects in CP-arm had lower average corrected count increments than LP-arm (mean [SD] 5.6 [4.20] vs. 22.6 [9.68] ×10 During shortages, CP may supplement LP in prophylactic transfusions of thrombocytopenic patients.
Sections du résumé
BACKGROUND
The short shelf-life of liquid-stored platelets (LP) at 20-24°C poses shortage and wastage challenges. Cryopreserved platelets have significantly extended shelf-life, and were safe and efficacious for therapeutic transfusions of bleeding patients in the Afghanistan conflict and phase 2 randomized studies. Although hematology patients account for half of platelets demand, there is no randomized study on prophylactic cryopreserved platelet transfusions in them.
METHODS
We performed a phase 1b/2a randomized cross-over study comparing the safety and efficacy of cryopreserved buffy coat-derived pooled platelets (CP) to LP in the prophylactic transfusions of thrombocytopenic hematology patients.
RESULTS
A total of 18 adults were randomly assigned 1:1 to CP and LP for their first thrombocytopenic period (TP) of up to 28-days. A total of 14 crossed over to the other platelet-arm for the second TP. Overall, 17 subjects received 51 CP and 15 received 52 LP. CP-arm had more treatment emergent adverse event (29.4% vs. 13.3% of subjects, 9.8% vs. 3.8% of transfusions) than LP-arm but all were mild. No thromboembolism was observed. Both arms had similar bleeding rates (23.5% vs. 26.7% of subjects) which were all mild. Subjects in CP-arm had lower average corrected count increments than LP-arm (mean [SD] 5.6 [4.20] vs. 22.6 [9.68] ×10
DISCUSSION
During shortages, CP may supplement LP in prophylactic transfusions of thrombocytopenic patients.
Types de publication
Randomized Controlled Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1649-1660Informations de copyright
© 2023 AABB.
Références
Stubbs JR, Shaz BH, Vasallo RR, et al. Expanding the platelet inventory to mitigate the impact of severe shortages. Hematology Am Soc Hematol Educ Program. 2022;424-429:424-429.
Milford EM, Reade MC. Comprehensive review of platelet storage methods for use in the treatment of active hemorrhage. Transfusion. 2016;56:S140-S180.
Noorman F, van Dongen TT, Plat MJ, et al. Transfusion: −80°C frozen blood products are safe and effective in military casualty care. PloS One. 2016;11:e0168401. https://doi.org/10.1371/journal.pone.0168401
Khuri SF, Healey N, MacGregor H, Barnard MR, Szymanski IO, Birjiniuk V, et al. Comparison of the effects of transfusions of cryopreserved and liquid-preserved platelets on hemostasis and blood loss after cardiopulmonary bypass. J Thorac Cardiovasc Surg. 1999;117:172-183.
Reade MC, Marks DC, Bellomo R, Deans R, Faulke DJ, Fraser JF, et al. A randomized, controlled pilot clinical trial of cryopreserved platelets for perioperative surgical bleeding: the CLIP-I trial. Transfusion. 2019;59:2794-2804.
Slichter SJ, Dumont LJ, Cancelas JA, Jones ML, Gernsheimer TB, Szczepiorkowski ZM, et al. Safety and efficacy of cryopreserved platelets in bleeding patients with thrombocytopenia. Transfusion. 2018;58:2129-2138.
Lelkens CCM, Koning JG, de Kort B, Floot IBG, Noorman F. Experiences with frozen blood products in The Netherlands military. Transfus Apher Sci. 2006;34:289-298.
Slichter SJ, Jones M, Ransom J, Gettinger I, Jones MK, Christoffel T, et al. Review of In vivo studies of dimethyl sulfoxide cryopreserved platelets. Transfus Med Rev. 2014;28:212-225.
Johnson L, Tan S, Jenkins E, Wood B, Marks DC. Characterization of biologic response modifiers in the supernatant of conventional, refrigerated, and cryopreserved platelets. Transfusion. 2018;58:927-937.
Gerber B, Alberio L, Rochat S, Stenner F, Manz MG, Buser A, et al. Safety and efficacy of cryopreserved autologous platelet concentrates in HLA-alloimmunized patients with hematologic malignancies. Transfusion. 2016;56:2426-2437.
Napolitano M, Mancuso S, Raso S, LoCoco L, Arfò PS, de Francisci G, et al. Buffy coat-derived platelets cryopreserved using a new method: results from a pivotal clinical trial on thrombocytopenic patients with acute leukaemia. Tranfus Apher Sci. 2019;58:102666. https://doi.org/10.1016/j.transci.2019.10.008
Bohonek M, Kutac D, Landova L, Koranova M, Sladkova E, Staskova E, et al. The use of cryopreserved platelets in the treatment of polytraumatic patients and patients with massive bleeding. Transfusion. 2019;59:1474-1478.
Dyer C, Alquist CR, Cole-Sinclair M, Curnow E, Dunbar NM, Estcourt LJ, et al. A multicentred study to validate a consensus bleeding assessment tool developed by the biomedical excellence for safer transfusion collaborative for use in patients with haematological malignancy. Vox Sang. 2018;113:251-259.
Gottschall J, Wu YY, Triulzi D, Kleinman S, Strauss R, Zimrin AB, et al. The epidemiology of platelet transfusions: analysis of platelet use at 12 US hospitals. Transfusion. 2020;60:46-53.
Schiffer CA, Aisner J, Wiernik PH. Clinical experience with transfusion of cryopreserved platelets. Br J Haematol. 1976;34:377-385.
Daly PA, Schiffer CA, Aisner J, Wiernik PH. Successful transfusion of platelets cryopreserved for more than 3 years. Blood. 1979;54:1023-1027.
Lazarus HM, Kaniecki-Green EA, Warm SE, Aikawa M, Herzig RH. Therapeutic effectiveness of frozen platelet concentrates for transfusion. Blood. 1981;57:243-249.
Melaragno AJ, Carciero R, Feingold H, Talarico L, Weintraub L, Valeri CR. Cryopreservation of human platelets using 6% dimethyl sulfoxide and storage at −80 degrees C. Effects of 2 years of frozen storage at −80 degrees C and transportation in dry ice. Vox Sang. 1985;49:245-258.
Stanworth SJ, Estcourt LJ, Powter G, Kahan BC, Dyer C, Choo L, et al. A no-prophylaxis platelet-transfusion strategy for hematologic cancers. N Engl J Med. 2013;368:1771-1780.
Slichter SJ, Kaufman RM, Assmann SF, McCullough J, Triulzi DJ, Strauss RG, et al. Dose of prophylactic platelet transfusions and prevention of hemorrhage. N Engl J Med. 2010;362:600-613.