Use of Cell Salvage Post-operatively in Infants to Decrease Use of Allogeneic Blood Product Transfusions

Study Overview
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Brief Summary
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Transfusion of washed intra-operative cell salvage post-operatively in the PCICU can be performed safely without increased risk of bleeding or release of inflammatory mediators. This will reduce the need for allogeneic blood products as well as crystalloid and colloid infusions and thus decrease the length of ventilation and intensive care duration for these infants.

Official Title
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Post-operative Infusion of Intra-operative Cell Salvage Reduces Allogeneic Blood Product Transfusions and Volume Resuscitation in Pediatric Cardiac Surgery and Improves Clinical Outcomes

Conditions
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Transfusion

Intervention / Treatment
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* Other: Cell Saver RBCs
* Other: Conventional volume infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Weight < or = 20Kg; 2. Cardiac surgery with CPB at URMC; 3. informed consent Exclusion Criteria: 1. weight > 21 Kg; inability to obtain consent; non-English speaking
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: Conventional Transfusion<br>Infants will receive PRBCs, crystalloid, and colloid for hemodynamic instability per the usual routine at the discretion of the attending intensive care physician | Other: Conventional volume infusion<br>* Infusion of allogeneic PRBCs, crystalloid, and colloid as needed for hemodynamic instability<br>|
| Experimental: Cell Saver<br>Infants will receive washed cell-saver RBCs for hemodynamic instability in the first 24 hours post-operative period as long as Hgb is < 13 gm/dL and cell-saver is available. | Other: Cell Saver RBCs<br>* Use of cell saver RBCs to decrease the infusion of allogeneic PRBCs, crystalloid, and colloid in post-operative infants following CPB as needed for hemodynamic instability<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of volume of allogeneic blood products and crystalloid/colloid infusions between groups | To compare the volume of allogeneic blood products and crystalloid/colloid infusions between patients randomized to receive washed intra-operative cell salvage vs our current standard for volume replacement for the first 24 hours post-op | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of bleeding, use of coagulant products, and inflammatory markers between groups | To compare measures of bleeding (MT drainage, Hgb, platelet counts) , the use of coagulant products (FFP, platelets, cryoprecipitate) and inflammatory/immunomodulatory markers [C-reactive protein (CRP) and IL-6/IL-10 ratio]between patients randomized to receive washed intra-operative cell salvage vs our current standard of care for volume replacement. | 2 years | 
| comparison of clinical outcomes between groups | To compare clinical outcome measures (ventilator days, PCICU duration, thrombosis, bacterial infections and mortality) between patients randomized to receive washed intra-operative cell salvage vs our current standard of care for volume replacement. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cell saver, allogeneic RBCs, washed cells, PRBC transfusion