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

University of Rochester106 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

106

Conditions

Transfusion

Interventions

Cell Saver RBCsOTHER

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 infusionOTHER

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

University of Rochester Medical Center

Rochester, New York, United States

Outcomes

Primary Outcomes

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

Time frame: 2 years

Secondary Outcomes

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.

Time frame: 2 years

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.

Time frame: 2 years

Data from ClinicalTrials.gov

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