CHIlled Platelet Study (CHIPS)

  • STATUS
    Recruiting
  • End date
    Mar 31, 2024
  • participants needed
    1000
  • sponsor
    Philip Spinella
Updated on 21 October 2022

Summary

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
Condition Acute Blood Loss
Treatment Cold stored platelets, Room temperature platelets
Clinical Study IdentifierNCT04834414
SponsorPhilip Spinella
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age greater than 28 days and less than 85 years
Planned complex cardiac surgery with planned use of cardiopulmonary bypass

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 <75x10(9)/L, based on the most recent labs completed within 72 hours prior to the date of surgery
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