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

Not Applicable

Completed

• Conditions: Transfusion
• Interventions: Other: Conventional volume infusion; Other: Cell Saver RBCs

• Registration Number: NCT01211366
• Lead Sponsor: University of Rochester

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-28
• Study First Submitted QC: 2010-09-28
• Study First Posted: 2010-09-29
• Study Start: 2010-10
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-10
• Last Update Posted: 2012-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Transfusion	Conventional volume infusion	Infants will receive PRBCs, crystalloid, and colloid for hemodynamic instability per the usual routine at the discretion of the attending intensive care physician
Cell Saver	Cell Saver RBCs	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.

Primary Outcome Measures

Name	Time	Method
Comparison of volume of allogeneic blood products and crystalloid/colloid infusions between groups	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

Name	Time	Method
comparison of bleeding, use of coagulant products, and inflammatory markers between groups	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	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.

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States