Congenital Heart Disease, Impaired Oxygen Delivery
Conditions
Keywords
Hemoglobin, Congenital heart disease, Cardiac surgery, Red blood cell transfusion, Number of red blood cell transfusions
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.
Interventions
OTHERRed blood cell transfusion
10cc/kg weight RBC transfusion as needed according to hemoglobin level
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 7 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed