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

University of Rochester1 site in 1 country162 target enrollmentJanuary 2012

ConditionsImpaired Oxygen Delivery Congenital Heart Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Impaired Oxygen Delivery
Sponsor: University of Rochester
Enrollment: 162
Locations: 1
Primary Endpoint: oxygen utilization derived from the arterio-venous oxygen difference.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

September 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Rochester

Responsible Party

Principal Investigator

jill cholette

Assistant Professor of Pediatrics

University of Rochester

Eligibility Criteria

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.

Outcomes

Primary Outcomes

oxygen utilization derived from the arterio-venous oxygen difference.

Time Frame: 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.