Please use this identifier to cite or link to this item: http://ahro.austin.org.au/austinjspui/handle/1/23525
Title: A randomized, controlled pilot clinical trial of cryopreserved platelets for perioperative surgical bleeding: the CLIP-I trial (Editorial, p. 2759).
Authors: Reade, Michael C;Marks, Denese C;Bellomo, Rinaldo;Deans, Renae;Faulke, Daniel J;Fraser, John F;Gattas, David J;Holley, Anthony D;Irving, David O;Johnson, Lacey;Pearse, Bronwyn L;Royse, Alistair G;Wong, Janet
Affiliation: Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
Australian Red Cross Blood Service, Sydney, New South Wales, Australia
Austin Health, Heidelberg, Victoria, Australia
The Prince Charles Hospital, Brisbane, Queensland, Australia
University of Queensland, Brisbane, Queensland, Australia
Joint Health Command, Australian Defence Force, Canberra, Australian Capital Territory, Australia
Royal Melbourne Hospital, Melbourne, Victoria, Australia
Issue Date: Jul-2019
EDate: 2019-07-10
Citation: Transfusion 2019; 59(9): 2794-2804
Abstract: 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. 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 shroud placed over each study PLT unit. Up to 3 units of cryopreserved or liquid-stored PLTs were administered per patient. No other aspect of patient care was affected. Adverse events were actively sought. A total of 121 patients were randomized, of whom 23 received cryopreserved PLTs and 18 received liquid-stored PLTs. There were no differences in blood loss (median, 715 mL vs. 805 mL at 24 hr; difference between groups 90 mL [95% CI, -343.8 to 163.8 mL], p = 0.41), but the Bleeding Academic Research Consortium criterion for significant postoperative hemorrhage in cardiac surgery composite bleeding endpoint occurred in nearly twice as many patients in the liquid-stored group (55.6% vs. 30.4%, p = 0.10). Red blood cell transfusion requirements were a median of 3 units in the cryopreserved group versus 4 units with liquid-stored PLTs (difference between groups, 1 unit [95% CI, -3.1 to 1.1 units]; p = 0.23). Patients in the cryopreserved group were more likely to be transfused fresh-frozen plasma (78.3% vs. 27.8%, p = 0.002) and received more study PLT units (median, 2 units vs. 1 unit; difference between groups, 1 unit [95% CI, -0.03 to 2.0 units]; p = 0.012). There were no between-group differences in potential harms including deep venous thrombosis, myocardial infarction, respiratory function, infection, and renal function. No patient had died at 28 days, and postoperative length of stay was similar in each group. In this pilot RCT, compared to liquid-stored PLTs, cryopreserved PLTs were associated with no evidence of harm. A definitive study testing safety and hemostatic effectiveness is warranted.
URI: http://ahro.austin.org.au/austinjspui/handle/1/23525
DOI: 10.1111/trf.15423
ORCID: 0000-0003-1570-0707
0000-0002-3674-6934
0000-0002-1650-8939
0000-0002-7012-2519
0000-0002-9282-7093
0000-0001-8042-6084
0000-0003-3303-4437
0000-0002-4449-663X
PubMed URL: 31290573
Type: Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Appears in Collections:Journal articles

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