A Pilot Trial of Platelets Stored Cold versus at Room Temperature for Complex Cardiothoracic Surgery.
Strandenes, Geir M.D.; Sivertsen, Joar B.Sc.; Bjerkvig, Christopher K. M.D.; Fosse, Theodor K. M.D.; Cap, Andrew P. M.D., Ph.D.; del Junco, Deborah J. Ph.D.; Kristoffersen, Einar Klaeboe M.D., Ph.D.; Haaverstad, Rune M.D., Ph.D.; Kvalheim, Venny M.D., Ph.D.; Braathen, Hanne B.Sc.; Lunde, Turid Helen Felli M.Sc.; Hervig, Tor M.D., Ph.D.; Hufthammer, Karl Ove Ph.D.; Spinella, Philip C. M.D.; Apelseth, Torunn Oveland M.D., Ph.D.
133(6):1173-1183, December 2020.
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Background: This pilot trial focused on feasibility and safety to provide preliminary data to evaluate the hemostatic potential of cold-stored platelets (2[degrees] to 6[degrees]C) compared with standard room temperature-stored platelets (20[degrees] to 24[degrees]C) in adult patients undergoing complex cardiothoracic surgery. This study aimed to assess feasibility and to provide information for future pivotal trials.
Methods: A single center two-stage exploratory pilot study was performed on adult patients undergoing elective or semiurgent complex cardiothoracic surgery. In stage I, a two-armed randomized trial, platelets stored up to 7 days in the cold were compared with those stored at room temperature. In the subsequent single-arm stage II, cold storage time was extended to 8 to 14 days. The primary outcome was clinical effect measured by chest drain output. Secondary outcomes were platelet function measured by multiple electrode impedance aggregometry, total blood usage, immediate and long-term (28 days) adverse events, length of stay in intensive care, and mortality.
Results: In stage I, the median chest drain output was 720 ml (quartiles 485 to 1,170, n = 25) in patients transfused with room temperature-stored platelets and 645 ml (quartiles 460 to 800, n = 25) in patients transfused with cold-stored platelets. No significant difference was observed. The difference in medians between the room temperature- and cold-stored up to 7 days arm was 75 ml (95% CI, -220, 425). In stage II, the median chest drain output was 690 ml (500 to 1,880, n = 15). The difference in medians between the room temperature arm and the nonconcurrent cold-stored 8 to 14 days arm was 30 ml (95% CI, -1,040, 355). Platelet aggregation in vitro increased after transfusion in both the room temperature- and cold-stored platelet study arms. Total blood usage, number of adverse events, length of stay in intensive care, and mortality were comparable among patients receiving cold-stored and room temperature-stored platelets.
Conclusions: This pilot trial supports the feasibility of platelets stored cold for up to 14 days and provides critical guidance for future pivotal trials in high-risk cardiothoracic bleeding patients.
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