Assessing the Hemostatic Efficacy of Pathogen Reduced Platelets in Children Undergoing Cardiopulmonary Bypass Surgery: A Pilot Clinical Trial

Study Overview
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Brief Summary
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This study is testing whether pathogen reduced platelets can control bleeding as well as non-pathogen reduced platelets (otherwise known as large volume delayed sampling).

Detailed Description
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This is a pilot clinical trial to assess the post-operative bleeding in children who receive pathogen-reduced (PR) platelet transfusions versus standard (large volume delayed sampling - LVDS) platelet transfusions both during and for 24 hours following cardiopulmonary bypass surgery.

Official Title
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Assessing the Hemostatic Efficacy of Pathogen Reduced Platelets in Children Undergoing Cardiopulmonary Bypass Surgery: A Pilot Clinical Trial

Conditions
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Cardiopulmonary Bypass Surgery

Intervention / Treatment
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* Biological: Platelet Transfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 0 up to and including 18 years of age Undergoing elective cardiopulmonary bypass surgery Are planned to have a chest tube placed in the operating room prior to chest closure Exclusion Criteria: >/=19 years of age Preterm infants (less than 38-week gestational age at time of surgery) On extracorporeal membrane oxygenation (ECMO) or ventricular assist device prior to surgery Family requests limitation of blood products (i.e. Jehovah's Witness) Congenital bleeding disorder Are planned to require ECMO post-op Previously enrolled in the study

Ages Eligible for Study
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Maximum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pathogen-reduced (PR) platelet transfusions<br>FDA approved and already used in this patient population | Biological: Platelet Transfusion<br>* All platelet transfusions will be given as 10mL/kg as is considered standard of care.<br>|
| Active Comparator: Large volume delayed sampling - LVDS<br>FDA approved and already used in this patient population | Biological: Platelet Transfusion<br>* All platelet transfusions will be given as 10mL/kg as is considered standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative bleeding as measured by chest tube output for first 24 hours following cardiopulmonary bypass surgery | Chest tube output for first 24 hours following cardiopulmonary bypass surgery | Within the first 24 hours post-op. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dose red blood cell volume transfused in first 48 hours post-op | Total dose red blood cell volume transfused in first 48 hours post-op | During hospitalization in the first 48 hours (no follow-up visits necessary) | 
| Total platelet volume transfused in the first 48 hours post-op | Total platelet volume transfused in the first 48 hours post-op | During hospitalization in the first 48 hours (no follow-up visits necessary) | 
| Total plasma volume transfused in the first 48 hours post-op | Total plasma volume transfused in the first 48 hours post-op | During hospitalization in the first 48 hours (no follow-up visits necessary) | 
| Total cryoprecipitate volume transfused in the first 48 hours post-op. | Total cryoprecipitate volume transfused in the first 48 hours post-op. | During hospitalization in the first 48 hours (no follow-up visits necessary) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet Transfusion, LVDS platelet transfusion, PR platelet transfusion