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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:
Information provided by (Responsible Party):
jill cholette, University of Rochester
ClinicalTrials.gov Identifier:
NCT01211366
First received: September 28, 2010
Last updated: February 10, 2012
Last verified: February 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Comparison of volume of allogeneic blood products and crystalloid/colloid infusions between groups [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: jill cholette, Assistant Professor of Pediatrics, University of Rochester
ClinicalTrials.gov Identifier: NCT01211366     History of Changes
Other Study ID Numbers: 32600
Study First Received: September 28, 2010
Last Updated: February 10, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013