Restrictive Versus Liberal Transfusion Protocol in Infants Undergoing Cardiac Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Randomized Controlled Clinical Trial Comparing a Restrictive Versus Liberal Transfusion Strategy in Neonates and Infants Undergoing Surgery for Congenital Heart Disease

Conditions
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Impaired Oxygen Delivery, Congenital Heart Disease

Intervention / Treatment
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* Other: Red blood cell transfusion
* Other: Red blood cell transfusion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 7 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Restrictive transfusion strategy<br>RBC will be transfused if the hemoglobin level falls below 7 for bi-ventricular repairs and under 9.0 for single ventricle palliations. | Other: Red blood cell transfusion<br>* 10cc/kg weight RBC transfusion as needed according to hemoglobin level<br>|
| Experimental: Liberal RBC transfusion strategy<br>RBCs will be transfused for Hemoglobin under 9.5 for biventricular repairs and under 12 for single ventricle palliations. | Other: Red blood cell transfusion<br>* 10cc/kg weight RBC transfusion as needed according to hemoglobin level<br>Other: Red blood cell transfusion<br>* 10cc/kg body weight RBC will be transfused for hemoglobin under 9.5 for biventricular repairs and under 12 for single ventricle palliations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemoglobin, Congenital heart disease, Cardiac surgery, Red blood cell transfusion, Number of red blood cell transfusions