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CHIlled Platelet Study "CHIPS" (CHIPS)

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ClinicalTrials.gov Identifier: NCT04834414
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : March 6, 2023
Sponsor:
Collaborators:
University of Utah
University of Minnesota
Washington University School of Medicine
United States Department of Defense
Information provided by (Responsible Party):
Philip Spinella, University of Pittsburgh

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Acute Blood Loss Biological: Cold Stored Platelets Biological: Room Temperature Platelets Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Adaptive Design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Partial Blind
Primary Purpose: Treatment
Official Title: CHIlled Platelet Study
Actual Study Start Date : October 21, 2021
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Hemostatic efficacy [ Time Frame: 24 hours after first study platelet transfusion ]
    Assessed by a bleeding score, a modified Peri-Operative bleeding score: the score ranges from 1-5. A lower score signifies a better outcome.


Secondary Outcome Measures :
  1. Chest tube output [ Time Frame: 24 hours from first study platelet transfusion or ICU admit (determined from which occurs last) ]
    Assessed by volume


Other Outcome Measures:
  1. Blood product administration [ Time Frame: 24 and 72 hours from start time of first study platelet transfusion ]
    The quantity of RBCs, Plasma, Platelets, Cryoprecipitate, and Whole blood

  2. Total Dose of individual hemostatic adjuncts [ Time Frame: 24 and 72 hours from start time of first study platelet transfusion ]
    Antifibrinolytic and coagulation factor concentrates

  3. Mechanical ventilation [ Time Frame: up to 28 days after first study platelet transfusion ]
    Duration of mechanical ventilation days

  4. Length of stay [ Time Frame: up to 28 days ]
    ICU and hospital length of stay

  5. Relative change in hemostatic parameters [ Time Frame: 6 and 24 hours after first study platelet transfusion ]
    CBC (platelet count and hemoglobin), PT/INR, PTT, fibrinogen, and TEG

  6. Unplanned sternal closure delay [ Time Frame: prior to ICU admission ]
    Sternum left open after cardiac surgery

  7. Re-exploration for bleeding [ Time Frame: 24 hours first study platelet transfusion ]
    Return to OR after ICU admission

  8. Unplanned extracorporeal support post operatively [ Time Frame: within 48 hours of first study platelet transfusion ]
    Placed on ECMO

  9. Morbidities after ICU admission [ Time Frame: within 7 days of first study platelet transfusion ]
    Acute respiratory distress syndrome, need for and duration of renal support, renal failure, septic shock

  10. Measures of end organ injury [ Time Frame: within 48 hours of first study platelet transfusion ]
    If BUN, creatinine, lactate, troponin, alanine aminotransferase (ALT) are collected clinically.

  11. Transfusion associated adverse events [ Time Frame: within 7 days of first study platelet transfusion ]
    As per CDC guidelines

  12. Arterial thrombotic event [ Time Frame: within 7 days of first study platelet transfusion ]
    Stroke, MI

  13. Venous thrombotic event [ Time Frame: within 7 days of first study platelet transfusion ]
    Deep vein thrombosis or pulmonary embolism confirmed by ultrasound, venography, perfusion scan, spiral CT, MRI, or pulmonary angiogram

  14. All cause mortality [ Time Frame: up to 28 days ]
    Death for any reason


Eligibility Criteria
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Ages Eligible for Study:   29 Days to 84 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than 28 days and less than 85 years
  • Planned complex cardiac surgery with planned use of cardiopulmonary bypass

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04834414


Contacts
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Contact: Meghan Huff, BSN 314-362-1319 meghanhuff@wustl.edu
Contact: Christina Daniel, BSN christina.daniel@wustl.edu

Locations
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Sponsors and Collaborators
Philip Spinella
University of Utah
University of Minnesota
Washington University School of Medicine
United States Department of Defense
Investigators
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Principal Investigator: Philip C Spinella, MD University of Pittsburgh
Principal Investigator: Marie E Steiner, MD University of Minnesota
Principal Investigator: Nicole D Zantek, MD University of Minnesota
More Information
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Publications:

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Responsible Party: Philip Spinella, Professor- Surgery and Critical Care Medicine, Co- Director- Trauma and Transfusion Medicine Research Center, Associate Medical Director- Center for Military Medicine Research, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04834414    
Other Study ID Numbers: CHIPS
W81XWH2090021 ( Other Grant/Funding Number: DoD )
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: March 6, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philip Spinella, University of Pittsburgh:
platelets
cold-stored platelets
bleeding
hemostasis
complex cardiac surgery
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes