Restrictive Versus Liberal Transfusion Protocol in Infants Undergoing Cardiac Surgery

University of Rochester

Status: Completed

Conditions: Impaired Oxygen Delivery; Congenital Heart Disease

Treatments: Other: Red blood cell transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01484886

38569

Details and patient eligibility

About

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.

Enrollment: 162 patients

Sex: All

Ages: Under 7 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

Restrictive transfusion strategy

Experimental group

Description:

RBC will be transfused if the hemoglobin level falls below 7 for bi-ventricular repairs and under 9.0 for single ventricle palliations.

Treatment:

Other: Red blood cell transfusion

Other: Red blood cell transfusion

Liberal RBC transfusion strategy

Experimental group

Description:

RBCs will be transfused for Hemoglobin under 9.5 for biventricular repairs and under 12 for single ventricle palliations.

Treatment:

Other: Red blood cell transfusion

Other: Red blood cell transfusion