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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

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

ArmDescriptionAssigned Intervention
Active Comparator
Room Temperature Platelets
Platelets stored at 20-24 degrees Celsius
  • Biological: Room Temperature Platelets
    Platelets stored at 20-24 degrees Celsius
Experimental
Cold Stored Platelets
Platelets stored at 1-6 degree Celsius
  • Biological: Cold Stored Platelets
    Platelets stored at 1-6 degree Celsius

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536
Contact:
Kerrie Brewer

More Details

NCT ID
NCT04834414
Status
Recruiting
Sponsor
Philip Spinella

Study Contact

Meghan Huff, BSN
314-362-1319
meghanhuff@wustl.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.