NCT04834414

CHIlled Platelet Study "CHIPS"

Official Title:

CHIlled Platelet Study

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.

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

Disease(s) and\or Condition(s)

Acute Blood Loss

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: BIOLOGICAL
    • Name: Cold Stored Platelets
    • Description: Platelets stored at 1-6 degree Celsius
    • Arm Group Labels: Cold Stored Platelets
    • Type: BIOLOGICAL
    • Name: Room Temperature Platelets
    • Description: Platelets stored at 20-24 degrees Celsius
    • Arm Group Labels: Room Temperature Platelets
Sponsor
  • Philip Spinella