Use of Cell Salvage Post-operatively in Infants to Decrease Use of Allogeneic Blood Product Transfusions (cell salvage)

University of Rochester

Status: Completed

Conditions: Transfusion

Treatments: Other: Conventional volume infusion; Other: Cell Saver RBCs

Study type: Interventional

Funder types: Other

Identifiers

NCT01211366

32600

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Conventional Transfusion

Active Comparator group

Description:

Infants will receive PRBCs, crystalloid, and colloid for hemodynamic instability per the usual routine at the discretion of the attending intensive care physician

Treatment:

Other: Conventional volume infusion

Cell Saver

Experimental group

Description:

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.

Treatment:

Other: Cell Saver RBCs