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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01484886
Other study ID # 38569
Secondary ID
Status Completed
Phase N/A
First received November 12, 2011
Last updated September 4, 2014
Start date January 2012
Est. completion date September 2014

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Other:
Red blood cell transfusion
10cc/kg weight RBC transfusion as needed according to hemoglobin level
Red blood cell transfusion
10cc/kg body weight RBC will be transfused for hemoglobin under 9.5 for biventricular repairs and under 12 for single ventricle palliations.

Locations

Country Name City State
United States University of Rochester Medical Center Rochester New York

Sponsors (1)

Lead Sponsor Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

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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