Congenital Heart Disease Clinical Trial
Official title:
Prospective Randomized Controlled Clinical Trial Comparing a Restrictive Versus Liberal Transfusion Strategy in Neonates and Infants Undergoing Surgery for Congenital Heart Disease
Verified date | September 2014 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 162 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 7 Months |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester Medical Center | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | volume of RBC transfused | The total numbers of RBC transfusions given during the immediate post-op period (1st 7 days) will be compared between groups. | 7 days | Yes |
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