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

0 Days

Maximum Age

84 Years

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.