Status:
COMPLETED
Cardiopulmonary Circuits in the Pediatric Population
Lead Sponsor:
Emory University
Conditions:
Pediatric
Cardiac Surgery
Eligibility:
All Genders
Phase:
NA
Brief Summary
During open-heart surgery, blood flow is supported by a heart-lung machine that both pumps the blood and gives it oxygen. A problem associated with a heart-lung machine is the damage to some of the bl...
Detailed Description
The goal of this study is to compare the PC/SMART and PMEA treated circuits against each other and the current clinical standard (untreated) circuit with regard to blood component damage during CPB. ...
Eligibility Criteria
Inclusion
- patients electively scheduled for first time cardiac surgery requiring cardiopulmonary bypass
- weight between 5 kg and 10 kg
- signed informed consent
Exclusion
- patients requiring emergent cardiac surgery
- patients who have undergone prior cardiothoracic surgery
- documented coagulation disorders
- use of anticoagulant drugs or anti-platelet agents within 48 hours of surgery
- patients who require more than 4 hours of CPB or require a return to CPB
- informed consent not obtained.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00208728
Start Date
May 1 2003
End Date
June 1 2005
Last Update
November 27 2013
Active Locations (1)
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1
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322