Open Actively Recruiting

CHIlled Platelet Study "CHIPS"

About

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 stored platelets. The primary objective is to establish that cold stored platelets have a non-inferiority (or superiority) to room temperature platelets.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
29 Days
Maximum Age
84 Years

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.

Join this Trial

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Study Stats
Protocol No.
21-001058
Category
Anesthesiology & Perioperative Medicine
Contact
Jennifer Scovotti
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04834414
For detailed technical eligibility, visit ClinicalTrials.gov.