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Use of Cell Salvage Post-operatively in Infants to Decrease Use of Allogeneic Blood Product Transfusions (cell salvage)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01211366
First Posted: September 29, 2010
Last Update Posted: February 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
jill cholette, University of Rochester
  Purpose
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.

Condition Intervention
Transfusion Other: Cell Saver RBCs Other: Conventional volume infusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by jill cholette, University of Rochester:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 106
Study Start Date: October 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
  More Information

Responsible Party: jill cholette, Assistant Professor of Pediatrics, University of Rochester
ClinicalTrials.gov Identifier: NCT01211366     History of Changes
Other Study ID Numbers: 32600
First Submitted: September 28, 2010
First Posted: September 29, 2010
Last Update Posted: February 13, 2012
Last Verified: February 2012

Keywords provided by jill cholette, University of Rochester:
cell saver
allogeneic RBCs
washed cells
PRBC transfusion