Use of Cell Salvage Post-operatively in Infants to Decrease Use of Allogeneic Blood Product Transfusions (cell salvage)
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|ClinicalTrials.gov Identifier: NCT01211366|
Recruitment Status : Completed
First Posted : September 29, 2010
Last Update Posted : February 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Transfusion||Other: Cell Saver RBCs Other: Conventional volume infusion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Post-operative Infusion of Intra-operative Cell Salvage Reduces Allogeneic Blood Product Transfusions and Volume Resuscitation in Pediatric Cardiac Surgery and Improves Clinical Outcomes|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Active Comparator: Conventional Transfusion
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
Infusion of allogeneic PRBCs, crystalloid, and colloid as needed for hemodynamic instability
Experimental: Cell Saver
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
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
- Comparison of volume of allogeneic blood products and crystalloid/colloid infusions between groups [ Time Frame: 2 years ]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
- comparison of bleeding, use of coagulant products, and inflammatory markers between groups [ Time Frame: 2 years ]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.
- comparison of clinical outcomes between groups [ Time Frame: 2 years ]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.
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): NCT01211366
|United States, New York|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14642|