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OpenTrials
Completed

NCT Number: NCT01211366

Use of Cell Salvage Post-operatively in Infants to Decrease Use of Allogeneic Blood Product Transfusions

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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Key information

Conditions

Transfusion

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Conventional volume infusion

Other

Infusion of allogeneic PRBCs, crystalloid, and colloid as needed for hemodynamic instability

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study 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

Acronym: cell salvage

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 29, 2010
Registry last updated
Feb 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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