NCT01484886

Restrictive Versus Liberal Transfusion Protocol in Infants Undergoing Cardiac Surgery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 7 Months
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Impaired Oxygen Delivery
• Congenital Heart Disease

Interventions

Type	Name	Description
OTHER	Red blood cell transfusion	10cc/kg weight RBC transfusion as needed according to hemoglobin level
OTHER	Red blood cell transfusion	10cc/kg body weight RBC will be transfused for hemoglobin under 9.5 for biventricular repairs and under 12 for single ventricle palliations.

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2011-12-02
• Last updated: 2014-09-05

Locations

1 site across 1 country: United States