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The Cryopreserved vs. Liquid Platelets Trial

Study acronym: CLIP II
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study completion date: Sep 2024 to Nov 2025v15
  2. Primary completion date changed from estimate of Jul 2024 to Jul 17, 2024
    • Study completion date: Aug 2024 to Sep 2024
    v14
  3. Trial status: Recruiting to Active, Not Recruitingv13 Show 4 more changesShow less
    • Enrollment target: estimated 808 to confirmed 388
    • Primary completion date: Feb 2024 to Jul 2024
    • Study completion date: May 2024 to Aug 2024
    • Site details revised at 6 of 6 sites
  4. Primary completion date: Jun 2023 to Feb 2024
    • Study completion date: Dec 2023 to May 2024
    v12
  5. Re-verified, no change to tracked fieldsv11
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 2 to 6v10
  2. Re-verified, no change to tracked fieldsv9
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Sep 2021 to Aug 17, 2021
    v8
  4. Start date: May 2021 to Sep 2021
    • Primary completion date: Mar 2023 to Jun 2023
    • Study completion date: Jul 2023 to Dec 2023
    v7
  5. Start date: Feb 2021 to May 2021v6
  6. Start date: Dec 2020 to Feb 2021v5
  7. Eligibility criteria expanded, about 23 wordsv4
  8. Start date: Aug 2020 to Dec 2020v3
  9. Start date: Sep 2019 to Aug 2020
    • Primary completion date: Sep 2022 to Mar 2023
    • Study completion date: Dec 2022 to Jul 2023
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This trial is a phase III multicentre blinded randomised controlled clinical non-inferiority trial of cryopreserved platelets vs. conventional liquid-stored platelets for the management of surgical bleeding. The aim of the study is to assess the efficacy, safety and cost effectiveness of cryopreserved platelets, compared to conventional liquid-stored platelets, for the management of surgical bleeding. This trial will recruit cardiac surgical patients deemed to be at high risk of surgical bleeding and who may potentially require transfusion of platelets. It is estimated to require 808 high-risk cardiac surgical patients to be recruited, to obtain 202 patients who receive transfused study platelets for surgical bleeding.
Trial Details
NCT Number NCT03991481
Lead Sponsor Australian and New Zealand Intensive Care Research Centre
Collaborators: Australian Red Cross
Conditions
(from sponsor)		 Surgical Blood Loss, Hemorrhage
Related terms Blood Loss, Surgical, Hemorrhage
Enrollment 388 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov