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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Transfusion | Active Comparator | Infants will receive PRBCs, crystalloid, and colloid for hemodynamic instability per the usual routine at the discretion of the attending intensive care physician |
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| Cell Saver | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cell Saver RBCs | Other | 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 |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
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| Conventional volume infusion | Other | Infusion of allogeneic PRBCs, crystalloid, and colloid as needed for hemodynamic instability |
|
| 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 |