Restrictive Versus Liberal Transfusion Protocol in Infants Undergoing Cardiac Surgery

Not Applicable

Completed

• Conditions: Impaired Oxygen Delivery; Congenital Heart Disease
• Interventions: Other: Red blood cell transfusion

• 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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

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.

Read More

Exclusion Criteria

• presence of a known bleeding disorder or coagulopathy.
• age > 6 months,
• lack of informed consent.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liberal RBC transfusion strategy	Red blood cell transfusion	RBCs will be transfused for Hemoglobin under 9.5 for biventricular repairs and under 12 for single ventricle palliations.
Restrictive transfusion strategy	Red blood cell transfusion	RBC will be transfused if the hemoglobin level falls below 7 for bi-ventricular repairs and under 9.0 for single ventricle palliations.

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