CHIlled Platelet Study "CHIPS"

Description

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.

Conditions

Acute Blood Loss

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

CHIlled Platelet Study

CHIlled Platelet Study "CHIPS"

Condition
Acute Blood Loss
Intervention / Treatment

-

Contacts and Locations

Phoenix

Mayo Clinic Arizona, Phoenix, Arizona, United States, 85054

Tucson

Banner University Medical Center, Tucson, Arizona, United States, 85713

Los Angeles

Ronald Reagan UCLA Medical Center, Los Angeles, California, United States, 90095

Gainesville

University of Florida, Gainesville, Florida, United States, 32608

Chicago

Northwestern Memorial Hospital, Chicago, Illinois, United States, 60611

Maywood

Loyola Universtiy Medical Center, Maywood, Illinois, United States, 60153

Kansas City

University of Kansas Medical Center, Kansas City, Kansas, United States, 66103

Lexington

University of Kentucky, Lexington, Kentucky, United States, 40536

Baltimore

John Hopkins, Baltimore, Maryland, United States, 21287

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

0 Days to 84 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Philip Spinella,

Philip C Spinella, MD, STUDY_DIRECTOR, University of Pittsburgh

Marie E Steiner, MD, STUDY_DIRECTOR, University of Minnesota

Nicole D Zantek, MD, STUDY_DIRECTOR, University of Minnesota

Study Record Dates

2025-01-31