ANZICS CTG Endorsed Study
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
For logistic reasons and in order to use this scarce resource optimally, liquid-stored platelets with a shelf-life of 5 days are not stored in smaller hospitals. Cryopreservation in dimethylsulphoxide (DMSO) is a promising technology that would allow smaller hospitals to provide platelet transfusions, reduce overall wastage, and possibly produce better haemostasis.
The aim of this phase III clinical trial is to assess the efficacy, safety and cost effectiveness of cryopreserved platelets, compared to conventional liquid-stored platelets, for treatment of surgical bleeding.
Approximately 808 cardiac surgical patients at high risk of platelet transfusion will be recruited. Of these, it is expected that 202 will be transfused study platelets. A maximum of 3 units of study platelets will be given, after which open-label liquid stored platelets will be used.
Major Secondary Endpoints:
Michael Reade (Chair), Denese Marks (Deputy Chair; lead blood scientist), Michael Bailey, 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, and Erica Wood
Project Manager yet to be appointed
ANZIC-RC, Monash University
Australian Red Cross Blood Service
NZ Blood Service
808 patients randomised for 202 patients transfused
Applications submitted for:
Project Status as of June 2018
Awaiting results of application for NHMRC Project Grant submitted March 2018.
In the interim:
CTG ID No 1718-06
Michael Reade (mail)