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Completed

NCT Number: NCT04834414

CHIlled Platelet Study "CHIPS"

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.

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Key information

Conditions

Acute Blood Loss Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

0 day–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fiona Stanley Hospital, Murdoch, Western Australia, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cold Stored Platelets

Biological

Platelets stored at 1-6 degree Celsius

Room Temperature Platelets

Biological

Platelets stored at 20-24 degrees Celsius

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Philip Spinella

Other

Collaborators

  • United States Department of Defense
  • University of Minnesota
  • University of Pittsburgh
  • University of Utah
  • Washington University School of Medicine

Registry information

Official study title

CHIlled Platelet Study

Acronym: CHIPS

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2021
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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