Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1000 participants
INTERVENTIONAL
2021-10-21
2025-04-21
Brief Summary
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Extended Cold Stored Apheresis Platelets in Cardiac Surgery Patients
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Room Temperature Platelets
Platelets stored at 20-24 degrees Celsius
Room Temperature Platelets
Platelets stored at 20-24 degrees Celsius
Cold Stored Platelets
Platelets stored at 1-6 degree Celsius
Cold Stored Platelets
Platelets stored at 1-6 degree Celsius
Interventions
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Cold Stored Platelets
Platelets stored at 1-6 degree Celsius
Room Temperature Platelets
Platelets stored at 20-24 degrees Celsius
Eligibility Criteria
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Inclusion Criteria
* Planned complex cardiac surgery with planned use of cardiopulmonary bypass, with an expectation of bleeding requiring platelet transfusion.
Exclusion Criteria
* 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.
0 Days
84 Years
ALL
No
Sponsors
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University of Utah
OTHER
University of Minnesota
OTHER
Washington University School of Medicine
OTHER
United States Department of Defense
FED
University of Pittsburgh
OTHER
Philip Spinella
OTHER
Responsible Party
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Philip Spinella
Professor- Surgery and Critical Care Medicine, Co- Director- Trauma and Transfusion Medicine Research Center, Associate Medical Director- Center for Military Medicine Research
Principal Investigators
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Philip C Spinella, MD
Role: STUDY_DIRECTOR
University of Pittsburgh
Marie E Steiner, MD
Role: STUDY_DIRECTOR
University of Minnesota
Nicole D Zantek, MD
Role: STUDY_DIRECTOR
University of Minnesota
Locations
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Mayo Clinic Arizona
Phoenix, Arizona, United States
Banner University Medical Center
Tucson, Arizona, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
University of Florida
Gainesville, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Loyola Universtiy Medical Center
Maywood, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
John Hopkins
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Wake Forest
Winston-Salem, North Carolina, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
University of Texas Children's Medical Center
Dallas, Texas, United States
University of Texas Medical Center Clements
Dallas, Texas, United States
Baylor Texas Children's
Houston, Texas, United States
Memorial Hermann Texas Medical Center
Houston, Texas, United States
University of Wisconsin- Madison
Madison, Wisconsin, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Countries
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References
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Krachey E, Viele K, Spinella PC, Steiner ME, Zantek ND, Lewis RJ. The design of an adaptive clinical trial to evaluate the efficacy of platelets stored at low temperature in surgical patients. J Trauma Acute Care Surg. 2018 Jun;84(6S Suppl 1):S41-S46. doi: 10.1097/TA.0000000000001876.
Strandenes G, Sivertsen J, Bjerkvig CK, Fosse TK, Cap AP, Del Junco DJ, Kristoffersen EK, Haaverstad R, Kvalheim V, Braathen H, Lunde THF, Hervig T, Hufthammer KO, Spinella PC, Apelseth TO. A Pilot Trial of Platelets Stored Cold versus at Room Temperature for Complex Cardiothoracic Surgery. Anesthesiology. 2020 Dec 1;133(6):1173-1183. doi: 10.1097/ALN.0000000000003550.
Zantek ND, Steiner ME, VanBuren JM, Lewis RJ, Berry NS, Viele K, Krachey E, Dean JM, Nelson S, Spinella PC. Design and logistical considerations for the randomized adaptive non-inferiority storage-duration-ranging CHIlled Platelet Study. Clin Trials. 2023 Feb;20(1):36-46. doi: 10.1177/17407745221126423. Epub 2022 Dec 21.
Lewis AR, Peffley N, Klompas AM, Ashrani AA. Role of individual factor X concentrate pharmacokinetic studies in perioperative management of AL amyloidosis-associated acquired factor X deficiency. Transfusion. 2023 Sep;63(9):1773-1777. doi: 10.1111/trf.17477. Epub 2023 Jul 10.
Klompas AM, Stubbs J. Massive transfusion protocol: What's in a name? Transfusion. 2023 Apr;63(4):896-897. doi: 10.1111/trf.17297. No abstract available.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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W81XWH2090021
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CHIPS
Identifier Type: -
Identifier Source: org_study_id
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