CHIlled Platelet Study "CHIPS"
Purpose
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.
Condition
- Acute Blood Loss
Eligibility
- Eligible Ages
- Between 0 Days and 84 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Adaptive Design
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
- Masking Description
- Partial Blind
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Room Temperature Platelets |
Platelets stored at 20-24 degrees Celsius |
|
|
Experimental Cold Stored Platelets |
Platelets stored at 1-6 degree Celsius |
|
Recruiting Locations
Memorial Hermann Texas Medical Center
Houston, Texas 77030
Houston, Texas 77030
Contact:
Kristine Ali
Kristine Ali
More Details
- Status
- Recruiting
- Sponsor
- Philip Spinella