Phase
Condition
Hemorrhage
Treatment
Cold Stored Platelets
Room Temperature Platelets
Clinical Study ID
Ages < 84 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Viable neonates ≥ 3 kg at time of enrollment (as defined in Section 4.1) OR agegreater 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 anexpectation of bleeding requiring platelet transfusion.
Exclusion
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), ventricularassist device (VAD), and/or continuous renal replacement therapy (CRRT)/hemodialysis
Patients intended to receive whole blood either intra-operative or post-operativefor 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 themost recent labs completed within 72 hours prior to the date of surgery.
Study Design
Connect with a study center
Fiona Stanley Hospital
Murdoch, Western Australia 6150
AustraliaSite Not Available
Sir Charles Gairdner Hospital
Nedlands, Western Australia 6009
AustraliaSite Not Available
Mayo Clinic Arizona
Pheonix, Arizona 85054
United StatesSite Not Available
Mayo Clinic Arizona
Phoenix, Arizona 85054
United StatesSite Not Available
Banner University Medical Center
Tucson, Arizona 85713
United StatesSite Not Available
Banner University Medical Center
Tuscon, Arizona 85713
United StatesSite Not Available
Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
United StatesSite Not Available
University of Florida
Gainesville, Florida 32608
United StatesSite Not Available
Northwestern Memorial Hospital
Chicago, Illinois 60611
United StatesSite Not Available
Loyola Universtiy Medical Center
Maywood, Illinois 60153
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66103
United StatesSite Not Available
University of Kentucky
Lexington, Kentucky 40536
United StatesSite Not Available
John Hopkins
Baltimore, Maryland 21287
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
University of Minnesota
Minneapolis, Minnesota 55455
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Wake Forest
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Cincinnati Children's Hospital
Cincinnati, Ohio 45229
United StatesSite Not Available
Oregon Health and Science University
Portland, Oregon 97239
United StatesSite Not Available
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
University of Pittsburgh Pennsylvania
Pitts, Pennsylvania 15232
United StatesSite Not Available
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15232
United StatesSite Not Available
University of Pittsburgh Pennsylvania
Pittsburgh, Pennsylvania 15232
United StatesActive - Recruiting
Rhode Island Hospital
Providence, Rhode Island 02910
United StatesSite Not Available
University of Texas Children's Medical Center
Dallas, Texas 75235
United StatesSite Not Available
University of Texas Medical Center Clements
Dallas, Texas 75235
United StatesSite Not Available
Baylor Texas Children's
Houston, Texas 77030
United StatesSite Not Available
Memorial Hermann Texas Medical Center
Houston, Texas 77030
United StatesSite Not Available
University of Wisconsin- Madison
Madison, Wisconsin 53792
United StatesSite Not Available
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin 53215
United StatesSite Not Available
Children's Hospital of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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