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

Transfusion Clinical Trial

— cell salvage  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211366
• Other study ID #: 32600
• Status: Completed
• Phase: N/A
• First received: September 28, 2010
• Last updated: February 10, 2012
• Start date: October 2010
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Transfusion

Intervention

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
• Conventional volume infusion
Infusion of allogeneic PRBCs, crystalloid, and colloid as needed for hemodynamic instability

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years	Yes
Secondary	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.	2 years	Yes
Secondary	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.	2 years	Yes