A randomized, controlled pilot clinical trial of cryopreserved platelets for perioperative surgical bleeding: the CLIP-I trial
Michael C Reade, Denese C Marks, Rinaldo Bellomo, Renae Deans, Daniel J Faulke, John F Fraser, David J Gattas, Anthony D Holley, David O Irving, Lacey Johnson, Bronwyn L Pearse, Alistair G Royse, Janet Wong, Laurence Weinberg, Glenn Eastwood, Leah Peck, Helen Young, Sofia Sidiropoulos, Sarah Baulch, Amanda Dalyell Show all
Transfusion | WILEY | Published : 2019
BACKGROUND: Cryopreservation extends platelet (PLT) shelf life from 5 to 7 days to 2 to 4 years. However, only 73 patients have been transfused cryopreserved PLTs in published randomized controlled trials (RCTs), making safety data insufficient for regulatory approval. STUDY DESIGN AND METHODS: The Cryopreserved vs. Liquid Platelet (CLIP) study was a double-blind, pilot, multicenter RCT involving high-risk cardiothoracic surgical patients in four Australian hospitals. The objective was to test, as the primary outcome, the feasibility and safety of the protocol. Patients were allocated to study group by permuted block randomization, with patients and clinicians blinded by use of an opaque shr..View full abstract
The Data Safety Monitoring Committee was chaired by Dr Duncan Young of the University of Oxford. Shereen Tan and Ryan Hyland at the Australian Red Cross Blood Service provided technical assistance in the manufacture of study cryopreserved platelets. The study was supported by an Academic Enhancement Grant from the Australian and New Zealand College of Anesthetists (A$94,000), a Research and Development Grant from the Australian Red Cross Blood Service (A$50,000 plus in-kind support by provision of cryopreserved platelets), and in-kind support from Joint Health Command of the Australian Defence Force.