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
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Condition or disease | Intervention/treatment | Phase |
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Acute Blood Loss | Biological: Cold Stored Platelets Biological: Room Temperature Platelets | Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Room Temperature Platelets
Platelets stored at 20-24 degrees Celsius
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Biological: Room Temperature Platelets
Platelets stored at 20-24 degrees Celsius |
Experimental: Cold Stored Platelets
Platelets stored at 1-6 degree Celsius
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Biological: Cold Stored Platelets
Platelets stored at 1-6 degree Celsius |
- 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.
- Chest tube output [ Time Frame: 24 hours from first study platelet transfusion or ICU admit (determined from which occurs last) ]Assessed by volume
- 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
- 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
- Mechanical ventilation [ Time Frame: up to 28 days after first study platelet transfusion ]Duration of mechanical ventilation days
- Length of stay [ Time Frame: up to 28 days ]ICU and hospital length of stay
- 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
- Unplanned sternal closure delay [ Time Frame: prior to ICU admission ]Sternum left open after cardiac surgery
- Re-exploration for bleeding [ Time Frame: 24 hours first study platelet transfusion ]Return to OR after ICU admission
- Unplanned extracorporeal support post operatively [ Time Frame: within 48 hours of first study platelet transfusion ]Placed on ECMO
- 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
- 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.
- Transfusion associated adverse events [ Time Frame: within 7 days of first study platelet transfusion ]As per CDC guidelines
- Arterial thrombotic event [ Time Frame: within 7 days of first study platelet transfusion ]Stroke, MI
- 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
- All cause mortality [ Time Frame: up to 28 days ]Death for any reason

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 29 Days to 84 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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

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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
platelets cold-stored platelets bleeding hemostasis complex cardiac surgery |
Hemorrhage Pathologic Processes |