Restrictive Versus Liberal Transfusion Protocol in Infants Undergoing Cardiac Surgery

Not Applicable

Completed

• Conditions: Impaired Oxygen Delivery; Congenital Heart Disease

• Registration Number: NCT01484886
• Lead Sponsor: University of Rochester

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-12
• Study First Submitted QC: 2011-11-30
• Study First Posted: 2011-12-02
• Study Start: 2012-01
• Status Verified: 2014-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2014-09-04
• Last Update Posted: 2014-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
oxygen utilization derived from the arterio-venous oxygen difference.	3 days	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States