COMPLETED

CHIlled Platelet Study "CHIPS"

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

CHIlled Platelet Study

Quick Facts

Study Start:2021-10-21
Study Completion:2025-04-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04834414

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.

Ages Eligible for Study:0 Days to 84 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Planned complex cardiac surgery with planned use of cardiopulmonary bypass, with an expectation of bleeding requiring platelet transfusion.
  1. * Expected order for washed or volume reduced platelets
  2. * Patient with known anti-platelet antibodies
  3. * Platelet transfusion refractoriness due to anti-HLA antibodies
  4. * Known or suspected pregnancy
  5. * Previously randomized in this study
  6. * Conscious objection or unwillingness to receive blood products
  7. * Known IgA deficiency
  8. * Known congenital platelet disorder
  9. * Known congenital bleeding disorder
  10. * Planned post-operative extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), and/or continuous renal replacement therapy (CRRT)/ hemodialysis
  11. * Patients intended to receive whole blood either intra-operative or post-operative for bleeding
  12. * Platelet transfusion (of any type) within 24 hours prior to the date of surgery
  13. * 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.

Contacts and Locations

Principal Investigator

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 Locations (Sites)

Mayo Clinic Arizona
Pheonix, Arizona, 85054
United States
Banner University Medical Center
Tuscon, Arizona, 85713
United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
United States
University of Florida
Gainesville, Florida, 32608
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
Loyola Universtiy Medical Center
Maywood, Illinois, 60153
United States
University of Kansas Medical Center
Kansas City, Kansas, 66103
United States
University of Kentucky
Lexington, Kentucky, 40536
United States
John Hopkins
Baltimore, Maryland, 21287
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Wake Forest
Winston-Salem, North Carolina, 27157
United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
United States
Rhode Island Hospital
Providence, Rhode Island, 02910
United States
University of Texas Children's Medical Center
Dallas, Texas, 75235
United States
University of Texas Medical Center Clements
Dallas, Texas, 75235
United States
Baylor Texas Children's
Houston, Texas, 77030
United States
Memorial Hermann Texas Medical Center
Houston, Texas, 77030
United States
University of Wisconsin- Madison
Madison, Wisconsin, 53792
United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-21
Study Completion Date2025-04-21

Study Record Updates

Study Start Date2021-10-21
Study Completion Date2025-04-21

Terms related to this study

Keywords Provided by Researchers

  • platelets
  • cold-stored platelets
  • bleeding
  • hemostasis
  • complex cardiac surgery

Additional Relevant MeSH Terms

  • Acute Blood Loss