Restrictive Versus Liberal Transfusion Protocol in Infants Undergoing Cardiac Surgery

University of Rochester162 enrolled

Overview

In neonates and infants \</= 10 kg following cardiac surgery for congenital heart disease a more restrictive red blood cell (RBC) transfusion strategy will be as effective as, and possibly superior to, a liberal RBC strategy. Allowing lower hemoglobin concentration will not affect the cardiac or pulmonary status of the patient.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

162

Conditions

Impaired Oxygen Delivery Congenital Heart Disease

Interventions

Red blood cell transfusionOTHER

10cc/kg weight RBC transfusion as needed according to hemoglobin level

Red blood cell transfusionOTHER

10cc/kg body weight RBC will be transfused for hemoglobin under 9.5 for biventricular repairs and under 12 for single ventricle palliations.

Eligibility

Sex: ALLMax age: 7 Months

Medical Language ↔ Plain English

Inclusion Criteria: * children \</= 6 months of age with congenital cardiac disease undergoing cardiac surgery with cardiopulmonary bypass. Exclusion Criteria: * presence of a known bleeding disorder or coagulopathy. * age \> 6 months, * lack of informed consent.

Locations (1)

University of Rochester Medical Center

Rochester, New York, United States

Outcomes

Primary Outcomes

oxygen utilization derived from the arterio-venous oxygen difference.

Arterial and venous oxygen saturations will be measured every four hours x 48-72 hours and will be used to calculate arterio-venous oxygen content differences.

Time frame: 3 days

Secondary Outcomes

volume of RBC transfused

The total numbers of RBC transfusions given during the immediate post-op period (1st 7 days) will be compared between groups.

Time frame: 7 days

Data from ClinicalTrials.gov

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