CHIlled Platelet Study "CHIPS"

Last updated: March 3, 2025
Sponsor: Philip Spinella
Overall Status: Active - Recruiting

Phase

3

Condition

Hemorrhage

Treatment

Room Temperature Platelets

Cold Stored Platelets

Clinical Study ID

NCT04834414
CHIPS
W81XWH2090021
  • Ages < 84
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Viable neonates ≥ 3 kg at time of enrollment (as defined in Section 4.1) OR agegreater 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 anexpectation of bleeding requiring platelet transfusion.

Exclusion

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), ventricularassist device (VAD), and/or continuous renal replacement therapy (CRRT)/hemodialysis

  • Patients intended to receive whole blood either intra-operative or post-operativefor 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 themost recent labs completed within 72 hours prior to the date of surgery.

Study Design

Total Participants: 1000
Treatment Group(s): 2
Primary Treatment: Room Temperature Platelets
Phase: 3
Study Start date:
October 21, 2021
Estimated Completion Date:
May 31, 2025

Connect with a study center

  • Fiona Stanley Hospital

    Murdoch, Western Australia 6150
    Australia

    Active - Recruiting

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Mayo Clinic Arizona

    Pheonix, Arizona 85054
    United States

    Site Not Available

  • Mayo Clinic Arizona

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Banner University Medical Center

    Tucson, Arizona 85713
    United States

    Active - Recruiting

  • Banner University Medical Center

    Tuscon, Arizona 85713
    United States

    Site Not Available

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University of Florida

    Gainesville, Florida 32608
    United States

    Active - Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Completed

  • Loyola Universtiy Medical Center

    Maywood, Illinois 60153
    United States

    Completed

  • University of Kansas Medical Center

    Kansas City, Kansas 66103
    United States

    Active - Recruiting

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

  • John Hopkins

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Wake Forest

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Completed

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • University of Pittsburgh Pennsylvania

    Pitts, Pennsylvania 15232
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • University of Pittsburgh Pennsylvania

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island 02910
    United States

    Active - Recruiting

  • University of Texas Children's Medical Center

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • University of Texas Medical Center Clements

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • Baylor Texas Children's

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Memorial Hermann Texas Medical Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Wisconsin- Madison

    Madison, Wisconsin 53792
    United States

    Completed

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin 53215
    United States

    Completed

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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