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

Post-operative Infusion of Intra-operative Cell Salvage Reduces Allogeneic Blood Product Transfusions and Volume Resuscitation in Pediatric Cardiac Surgery and Improves Clinical Outcomes

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01211366

Acronym

cell salvage

Enrollment

106

Registered

2010-09-29

Start date

2010-10-31

Completion date

2011-12-31

Last updated

2012-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transfusion

Keywords

cell saver, allogeneic RBCs, washed cells, PRBC transfusion

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.

Interventions

OTHERCell 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

OTHERConventional volume infusion

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026