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CHIPS

  • Status
    Accepting Candidates
  • Age
    0 Days - 84 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

A phase 3 randomized partial blind storage duration ranging study in patients undergoing complex cardiac surgery that will compare the transfusion of cold stored platelets to standard room temperature stored platelets. The primary objective is to establish that cold stored platelets have a non-inferiority (or superiority) to room temperature platelets.

Details

Full study title CHIlled Platelet Study
Protocol number OCR40842
ClinicalTrials.gov ID NCT04834414
Phase Phase 3

Eligibility

Inclusion Criteria:

  • Viable neonates ≥ 3 kg at time of enrollment (as defined in Section 4.1) OR age greater than 28 days and less than 85 years of age at time of consent; AND

  • Planned complex cardiac surgery with planned use of cardiopulmonary bypass, with an expectation of bleeding requiring platelet transfusion.

Exclusion Criteria:

  • Expected order for washed or volume reduced platelets

  • Patient with known anti-platelet antibodies

  • Platelet transfusion refractoriness due to anti-HLA antibodies

  • Known or suspected pregnancy

  • Previously randomized in this study

  • Conscious objection or unwillingness to receive blood products

  • Known IgA deficiency

  • Known congenital platelet disorder

  • Known congenital bleeding disorder

  • Planned post-operative extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), and/or continuous renal replacement therapy (CRRT)/ hemodialysis

  • Patients intended to receive whole blood either intra-operative or post-operative for bleeding

  • Platelet transfusion (of any type) within 24 hours prior to the date of surgery

  • Pre-operative thrombocytopenia, defined as platelet count

Lead researcher

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.