Summary

Eligibility
for people ages up to 84 years (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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.

Official Title

CHIlled Platelet Study

Keywords

Acute Blood Loss, platelets, cold-stored platelets, bleeding, hemostasis, complex cardiac surgery, Hemorrhage, Cold Stored Platelets, Room Temperature Platelets

Eligibility

You can join if…

Open to people ages up to 84 years

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Ronald Reagan UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States
  • Mayo Clinic Arizona accepting new patients
    Phoenix Arizona 85054 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Philip Spinella
ID
NCT04834414
Phase
Phase 3 Blood Loss Research Study
Study Type
Interventional
Participants
Expecting 1000 study participants
Last Updated