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

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.

Primary Endpoint:

  • Volume of post-surgical bleeding in the first 12 hours from the time the surgeon starts to close the wound (non-inferiority design with a 20% / 200ml non-inferiority margin)

Major Secondary Endpoints:

  • Requirement for postoperative blood products
  • Volume of postoperative fluid resuscitation
  • Immediate, short term or medium term adverse effects, especially DMSO toxicity, infection, venous thromboembolism, arterial occlusion, need for surgical intervention, and acute respiratory distress.
  • ICU and hospital length of stay
  • Total estimated healthcare cost
  • 28-day mortality

Management Committee

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

Administering Institution

ANZIC-RC, Monash University

Collaborators

ANZCA CTN
Australian Red Cross Blood Service
NZ Blood Service

Sample Size

808 patients randomised for 202 patients transfused

Funding

Applications submitted for:

  • NHMRC Project Grant $1,686,170
  • Defence Innovation Hub Project Grant $2 million

Project Status as of June 2018

Awaiting results of application for NHMRC Project Grant submitted March 2018.

In the interim:

  • developing the ACSePT risk prediction tool for platelet transfusion that will be required as an enrolment criterion for the trial, using the ANZSCTS database
  • preparing the CLIP-I pilot trial results for publication

Reference

CTG ID No 1718-06

Contact

Michael Reade (mail)