CHIlled Platelet Study "CHIPS"

Philip Spinella

Status and phase: Enrolling; Phase 3

Conditions: Acute Blood Loss

Treatments: Biological: Cold Stored Platelets; Biological: Room Temperature Platelets

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04834414

W81XWH2090021 (Other Grant/Funding Number)

CHIPS

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: Under 84 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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1,000 participants in 2 patient groups

Room Temperature Platelets

Active Comparator group

Description:

Platelets stored at 20-24 degrees Celsius

Treatment:

Biological: Room Temperature Platelets

Cold Stored Platelets

Experimental group

Description:

Platelets stored at 1-6 degree Celsius

Treatment:

Biological: Cold Stored Platelets