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, 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
Administering Institution
ANZIC Research Centre, Monash University
Collaborators
ANZCA CTN, Australian Red Cross Blood Service, NZ Blood Service
Sample Size
808 patients randomised for 202 patients transfused
Funding
NHMRC Project Grant $1.825M
Project Status
Recruitment
Platelet production
After lengthy delays to study platelet production related to COVID, the study now has sufficient frozen platelets for 12 sites.
Blood service training
Life Blood is initiating site blood service training via zoom in order to progress this under COVID lockdown which has been a barrier to completing this training.
Study Site recruitment
Due to logistical issues around platelet supply and provision of freezers, 12 sites is optimal for this study. To date 12 sites have committed to the study.
Ethics & RGO
Lead ethics approval has been obtained and with 7 sites with RGO approval. Remaining sites have submitted to RGO with 2 sites soon to submit.
Recruitment start
1 site has commenced recruitment with another site to go LIVE next week. Other sites will go LIVE once blood service training has been completed.
Reference
CTG1718-06
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