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
1 other identifier
interventional
162
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2011
CompletedFirst Posted
Study publicly available on registry
December 2, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedSeptember 5, 2014
September 1, 2014
2.7 years
November 12, 2011
September 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
oxygen utilization derived from the arterio-venous oxygen difference.
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.
3 days
Secondary Outcomes (1)
volume of RBC transfused
7 days
Study Arms (2)
Restrictive transfusion strategy
EXPERIMENTALRBC will be transfused if the hemoglobin level falls below 7 for bi-ventricular repairs and under 9.0 for single ventricle palliations.
Liberal RBC transfusion strategy
EXPERIMENTALRBCs will be transfused for Hemoglobin under 9.5 for biventricular repairs and under 12 for single ventricle palliations.
Interventions
10cc/kg weight RBC transfusion as needed according to hemoglobin level
Eligibility Criteria
You may qualify if:
- children \</= 6 months of age with congenital cardiac disease undergoing cardiac surgery with cardiopulmonary bypass.
You may not qualify if:
- presence of a known bleeding disorder or coagulopathy.
- age \> 6 months,
- lack of informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rochester Medical Center
Rochester, New York, 14642, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics
Study Record Dates
First Submitted
November 12, 2011
First Posted
December 2, 2011
Study Start
January 1, 2012
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
September 5, 2014
Record last verified: 2014-09