Comparing cold-stored platelets to room temperature platelets in cardiac surgery
CHIlled Platelet Study
This study is testing if cold-stored platelets work as well or better than room temperature platelets to help patients of all ages who need transfusions during complex heart surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 0 Days to 84 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 27 sites (Phoenix, Arizona and 26 other locations) |
| Trial ID | NCT04834414 on ClinicalTrials.gov |
What this trial studies
This phase 3 interventional study aims to evaluate the effectiveness of cold-stored platelets compared to standard room temperature stored platelets in patients undergoing complex cardiac surgery. The study will involve a randomized partial blind design to assess whether cold-stored platelets are non-inferior or superior in their ability to support hemostasis during surgery. Participants will include viable neonates and children to adults who are expected to require platelet transfusions due to anticipated bleeding. The primary goal is to improve patient outcomes related to blood loss management during surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 3 kg and above who are scheduled for complex cardiac surgery with an expected need for platelet transfusion.
Not a fit: Patients who are expected to receive washed or volume reduced platelets, or those with known platelet transfusion refractoriness, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved transfusion practices and better outcomes for patients undergoing complex cardiac surgeries.
How similar studies have performed: Other studies have explored the use of cold-stored platelets, but this specific approach in the context of complex cardiac surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Phoenix, Arizona and 26 other locations
- Mayo Clinic Arizona — Phoenix, Arizona, United States (Recruiting)
- Banner University Medical Center — Tucson, Arizona, United States (Recruiting)
- Ronald Reagan UCLA Medical Center — Los Angeles, California, United States (Recruiting)
- University of Florida — Gainesville, Florida, United States (Recruiting)
- Northwestern Memorial Hospital — Chicago, Illinois, United States (Completed)
- Loyola Universtiy Medical Center — Maywood, Illinois, United States (Completed)
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
- John Hopkins — Baltimore, Maryland, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Wake Forest — Winston-Salem, North Carolina, United States (Recruiting)
- Cincinnati Children's Hospital — Cincinnati, Ohio, United States (Recruiting)
- Oregon Health and Science University — Portland, Oregon, United States (Completed)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- Rhode Island Hospital — Providence, Rhode Island, United States (Recruiting)
- University of Texas Children's Medical Center — Dallas, Texas, United States (Recruiting)
- University of Texas Medical Center Clements — Dallas, Texas, United States (Recruiting)
- Baylor Texas Children's — Houston, Texas, United States (Recruiting)
- Memorial Hermann Texas Medical Center — Houston, Texas, United States (Recruiting)
- University of Wisconsin- Madison — Madison, Wisconsin, United States (Completed)
- Aurora St. Luke's Medical Center — Milwaukee, Wisconsin, United States (Completed)
- Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
- Fiona Stanley Hospital — Murdoch, Western Australia, Australia (Recruiting)
- Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia (Recruiting)
Study contacts
- Study coordinator: Meghan Huff, BSN
- Email: meghanhuff@wustl.edu
- Phone: 314-362-1319
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.