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

NCT01211366 | Completed DMC

• 1 other identifier: 32600
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Transfusion

Keywords

cell saver; allogeneic RBCs; washed cells; PRBC transfusion

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• comparison of bleeding, use of coagulant products, and inflammatory markers between groups

  2 years

• comparison of clinical outcomes between groups

  2 years

Study Arms (2)

Conventional Transfusion

ACTIVE COMPARATOR

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

Cell Saver

EXPERIMENTAL

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

Interventions

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

Cell Saver

Conventional volume infusion OTHER

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

Conventional Transfusion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Weight \< or = 20Kg;
• \. Cardiac surgery with CPB at URMC;
• \. informed consent

You may not qualify if:

• \. weight \> 21 Kg;
• inability to obtain consent;
• non-English speaking

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: September 29, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 13, 2012

Record last verified: 2012-02

Locations

US (1)