CHIlled Platelet Study "CHIPS"

Summary

A phase 3 randomized partial blind storage duration ranging study in patients undergoing complex cardiac surgery that will compare the transfusion of cold stored platelets to standard room temperature stored platelets. The primary objective is to establish that cold stored platelets have a non-inferiority (or superiority) to room temperature platelets.

Timeline

Start

2021-10-21

Primary completion

2025-03-25

Completion

2025-04-21

Publications

• Background Krachey E, Viele K, Spinella PC, Steiner ME, Zantek ND, Lewis RJ. The design of an adaptive clinical trial to evaluate the efficacy of platelets stored at low temperature in surgical patients. J Trauma Acute Care Surg. 2018 Jun;84(6S Suppl 1):S41-S46. doi: 10.1097/TA.0000000000001876.
• Background Strandenes G, Sivertsen J, Bjerkvig CK, Fosse TK, Cap AP, Del Junco DJ, Kristoffersen EK, Haaverstad R, Kvalheim V, Braathen H, Lunde THF, Hervig T, Hufthammer KO, Spinella PC, Apelseth TO. A Pilot Trial of Platelets Stored Cold versus at Room Temperature for Complex Cardiothoracic Surgery. Anesthesiology. 2020 Dec 1;133(6):1173-1183. doi: 10.1097/ALN.0000000000003550.
• Background Zantek ND, Steiner ME, VanBuren JM, Lewis RJ, Berry NS, Viele K, Krachey E, Dean JM, Nelson S, Spinella PC. Design and logistical considerations for the randomized adaptive non-inferiority storage-duration-ranging CHIlled Platelet Study. Clin Trials. 2023 Feb;20(1):36-46. doi: 10.1177/17407745221126423. Epub 2022 Dec 21.
• Lewis AR, Peffley N, Klompas AM, Ashrani AA. Role of individual factor X concentrate pharmacokinetic studies in perioperative management of AL amyloidosis-associated acquired factor X deficiency. Transfusion. 2023 Sep;63(9):1773-1777. doi: 10.1111/trf.17477. Epub 2023 Jul 10.
• Klompas AM, Stubbs J. Massive transfusion protocol: What's in a name? Transfusion. 2023 Apr;63(4):896-897. doi: 10.1111/trf.17297. No abstract available.

Drugs

Indications

No indication recorded.