ANZICS CTG Endorsed Study
CLIP II
A phase III multicentre blinded randomised controlled clinical non-inferiority trial of cryopreserved platelets vs. conventional liquid-stored platelets for the management of post-surgical bleeding. The cryopreserved vs. liquid platelets trial
Study Description
Platelet transfusion is essential to treat major bleeding. However, liquid-stored platelets have only a 5-day shelf-life. To use this scarce resource optimally, liquid-stored platelets are not kept in smaller hospitals, including military hospitals. Cryopreservation, developed by the US Navy, might allow smaller hospitals to provide platelets and reduce wastage by extending shelf-life to 2 years. Cryopreserved platelets were given to Australian soldiers in Afghanistan, 2006-2010, with apparently good effect. However, supporting evidence is limited to animal and in vitro studies and a single trial in which 24 patients were transfused. While universally encouraging, this is insufficient to justify change in practice.
This phase III study builds on our pilot trial, enrolling 808 cardiac surgical patients at high risk of perioperative bleeding. Cardiac surgical patients will be studied as they more commonly require platelet transfusion than any other surgical group, and because blood loss is easily measured in surgical drains. If platelets are required, up to three study platelet units (liquid or cryopreserved) will be transfused. The primary endpoint will be blood loss through the surgical drains in the 24 hours after surgery. Secondary endpoints will be adverse reactions, transfusion requirement, need for reoperation, cost, length of stay, and mortality. If cryopreserved platelets are not inferior to liquid-stored platelets, the logistic advantages of their longer shelf-life would justify rapid change in clinical practice worldwide. The research is therefore timely, feasible, justified by encouraging but incomplete evidence, and of high impact worldwide.
Management Committee
Michael Reade (Chair), Denese Marks, Paul Bannon, Richard Charlewood, Glenn Eastwood, Craig French, David Gattas, Lisa Higgins, Anthony Holley, Raymond Hu, David Irving, Lacey Johnson, Shay McGuiness, Zoe McQuilten, Alistair Royse, Julian Smith, Laurence Weinberg, Erica Wood, Belinda Howe, Ray Hu
Administering Institution
ANZIC RC, Monash University
Collaborators
ANZCA CTN, Australian Red Cross Blood Service, NZ Blood Service
Sample Size
808 patients
Funding
NHMRC
Reference
CTG1718-06, NCT03991481
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