An interventional study of Cell Saver RBCs and Conventional volume infusion in Transfusion, sponsored by University of Rochester. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2012-02-13.
Sponsored by University of Rochester · Not applicable, Interventional, and Treatment
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.
University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Infusion of allogeneic PRBCs, crystalloid, and colloid as needed for hemodynamic instability
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
Time frame: 2 years
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.
Time frame: 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.
Time frame: 2 years
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Rochester