A randomized, controlled pilot clinical trial of cryopreserved platelets for perioperative surgical bleeding: the CLIP-I trial (Editorial, p. 2759).

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  • Additional Information
    • Affiliation:
      Joint Health Command, Australian Defence Force, Canberra Australian Capital Territory, Australia
      University of Queensland, Brisbane Queensland, Australia
      Australian Red Cross Blood Service, Sydney New South Wales, Australia
      Austin Hospital, Melbourne Victoria, Australia
      The Prince Charles Hospital, Brisbane Queensland, Australia
      Royal Prince Alfred Hospital, Sydney New South Wales, Australia
      Royal Melbourne Hospital, Melbourne Victoria, Australia
    • Corporate Authors:
    • Subject Terms:
    • Subject Terms:
    • Abstract:
      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 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.Results: 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.Conclusion: 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.
    • Journal Subset:
      Allied Health; Biomedical; Peer Reviewed; USA
    • Instrumentation:
      Bleeding Index
      Clinical Decision Making in Nursing Scale (CDMNS) (Jenkins)
      Longitudinal Interval Follow-Up Evaluation (LIFE)
    • ISSN:
      0041-1132
    • MEDLINE Info:
      PMID: NLM31290573 NLM UID: 0417360
    • Grant Information:
      Academic Enhancement Grant 2013//Australian and New Zealand College of Anaesthetists/; Development Grant//Australian Red Cross Blood Service/
    • Publication Date:
      20200514
    • Publication Date:
      20200611
    • DOI:
      http://dx.doi.org/10.1111/trf.15423
    • Accession Number:
      138440894
  • Citations
    • ABNT:
      READE, M. C. et al. A randomized, controlled pilot clinical trial of cryopreserved platelets for perioperative surgical bleeding: the CLIP-I trial (Editorial, p. 2759). Transfusion, [s. l.], v. 59, n. 9, p. 2794–2804, 2019. DOI 10.1111/trf.15423. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=rzh&AN=138440894. Acesso em: 14 ago. 2020.
    • AMA:
      Reade MC, Marks DC, Bellomo R, et al. A randomized, controlled pilot clinical trial of cryopreserved platelets for perioperative surgical bleeding: the CLIP-I trial (Editorial, p. 2759). Transfusion. 2019;59(9):2794-2804. doi:10.1111/trf.15423
    • APA:
      Reade, M. C., Marks, D. C., Bellomo, R., Deans, R., Faulke, D. J., Fraser, J. F., Gattas, D. J., Holley, A. D., Irving, D. O., Johnson, L., Pearse, B. L., Royse, A. G., Wong, J., Weinberg, L., Eastwood, G., Peck, L., Young, H., Sidiropoulos, S., Baulch, S., & Dalyell, A. (2019). A randomized, controlled pilot clinical trial of cryopreserved platelets for perioperative surgical bleeding: the CLIP-I trial (Editorial, p. 2759). Transfusion, 59(9), 2794–2804. https://doi.org/10.1111/trf.15423
    • Chicago/Turabian: Author-Date:
      Reade, Michael C., Denese C. Marks, Rinaldo Bellomo, Renae Deans, Daniel J. Faulke, John F. Fraser, David J. Gattas, et al. 2019. “A Randomized, Controlled Pilot Clinical Trial of Cryopreserved Platelets for Perioperative Surgical Bleeding: The CLIP-I Trial (Editorial, p. 2759).” Transfusion 59 (9): 2794–2804. doi:10.1111/trf.15423.
    • Harvard:
      Reade, M. C. et al. (2019) ‘A randomized, controlled pilot clinical trial of cryopreserved platelets for perioperative surgical bleeding: the CLIP-I trial (Editorial, p. 2759)’, Transfusion, 59(9), pp. 2794–2804. doi: 10.1111/trf.15423.
    • Harvard: Australian:
      Reade, MC, Marks, DC, Bellomo, R, Deans, R, Faulke, DJ, Fraser, JF, Gattas, DJ, Holley, AD, Irving, DO, Johnson, L, Pearse, BL, Royse, AG, Wong, J, Weinberg, L, Eastwood, G, Peck, L, Young, H, Sidiropoulos, S, Baulch, S & Dalyell, A 2019, ‘A randomized, controlled pilot clinical trial of cryopreserved platelets for perioperative surgical bleeding: the CLIP-I trial (Editorial, p. 2759)’, Transfusion, vol. 59, no. 9, pp. 2794–2804, viewed 14 August 2020, .
    • MLA:
      Reade, Michael C., et al. “A Randomized, Controlled Pilot Clinical Trial of Cryopreserved Platelets for Perioperative Surgical Bleeding: The CLIP-I Trial (Editorial, p. 2759).” Transfusion, vol. 59, no. 9, Sept. 2019, pp. 2794–2804. EBSCOhost, doi:10.1111/trf.15423.
    • Chicago/Turabian: Humanities:
      Reade, Michael C., Denese C. Marks, Rinaldo Bellomo, Renae Deans, Daniel J. Faulke, John F. Fraser, David J. Gattas, et al. “A Randomized, Controlled Pilot Clinical Trial of Cryopreserved Platelets for Perioperative Surgical Bleeding: The CLIP-I Trial (Editorial, p. 2759).” Transfusion 59, no. 9 (September 2019): 2794–2804. doi:10.1111/trf.15423.
    • Vancouver/ICMJE:
      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 (Editorial, p. 2759). Transfusion [Internet]. 2019 Sep [cited 2020 Aug 14];59(9):2794–804. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=rzh&AN=138440894