CHIlled Platelet Study CHIPS

Study Overview
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Brief Summary
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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.

Official Title
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CHIlled Platelet Study

Conditions
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Acute Blood Loss

Intervention / Treatment
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* Biological: Cold Stored Platelets
* Biological: Room Temperature Platelets


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 29 Days
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Adaptive Design
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Room Temperature Platelets<br>Platelets stored at 20-24 degrees Celsius | Biological: Room Temperature Platelets<br>* Platelets stored at 20-24 degrees Celsius<br>|
| Experimental: Cold Stored Platelets<br>Platelets stored at 1-6 degree Celsius | Biological: Cold Stored Platelets<br>* Platelets stored at 1-6 degree Celsius<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest tube output | Assessed by volume | 24 hours from first study platelet transfusion or ICU admit (determined from which occurs last) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelets, cold-stored platelets, bleeding, hemostasis, complex cardiac surgery