CHIlled Platelet Study "CHIPS"

Completed · Phase 3

Conditions studied: Acute Blood Loss

In brief

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.

Key facts

Study ID

NCT04834414

Run by

Philip Spinella

People needed

1000

Starts

2021-10-21

Expected to finish

2025-04-21

Last updated by the study team

2025-07-11

Who can join

Age: any, up to 84. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• Mayo Clinic Arizona — Phoenix, Arizona, United States
• Banner University Medical Center — Tucson, Arizona, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• University of Florida — Gainesville, Florida, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Loyola Universtiy Medical Center — Maywood, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• John Hopkins — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Wake Forest — Winston-Salem, North Carolina, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• University of Texas Children's Medical Center — Dallas, Texas, United States
• University of Texas Medical Center Clements — Dallas, Texas, United States
• Baylor Texas Children's — Houston, Texas, United States
• Memorial Hermann Texas Medical Center — Houston, Texas, United States
• University of Wisconsin- Madison — Madison, Wisconsin, United States
• Aurora St. Luke's Medical Center — Milwaukee, Wisconsin, United States
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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