Status:
COMPLETED
CHIlled Platelet Study "CHIPS"
Lead Sponsor:
Philip Spinella
Collaborating Sponsors:
University of Utah
University of Minnesota
Conditions:
Acute Blood Loss
Eligibility:
All Genders
Up to 84 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2025
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04834414
Start Date
October 21 2021
End Date
April 21 2025
Last Update
July 11 2025
Active Locations (27)
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1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
2
Banner University Medical Center
Tucson, Arizona, United States, 85713
3
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
4
University of Florida
Gainesville, Florida, United States, 32608