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NCT00208728 · ClinicalTrials.gov registry record · NA
Cardiopulmonary Circuits in the Pediatric Population
A NA study, sponsored by Emory University.
- Completed
- Registry status
- NA
- Development phase
- 90
- Enrollment target
NCT00208728: Completed NA study, sponsored by Emory University.
NCT00208728 is a NA study that has completed, run by Emory University. The registered enrollment target is 90 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00208728, a NA study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
Study 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 blood caused by protein in the blood cell sticking to the sides of the heart-lung machine tubing. This breakdown of the blood cell affects the platelets, which help the blood to clot. Use of the un-treated circuit will be phased out within the next few years, as newer technology is available. The use of coated tubing has been shown to decrease problems with post-operative bleeding in the adult population. No studies have been done on the pediatric population. We plan to perform a prospective, randomized study using the un-treated circuits used now, the " Smart" circuit tubing manufactured by Cobe Cardiovascular Inc., Arvada, CO and the PMEA circuit manufactured by Terumo Corporation, Tokyo, Japan. Randomization will be performed by the perfusionist (the person that runs the heart-lung machine) in charge of the case. No one else will be aware of which circuit is being used. There will be no changes in the operation of the heart-lung machine, anesthesia or the surgery because of this study. Blood testing that is standard of care and some additional tests will be performed on a small amount of blood drawn from. the patient via arterial lines. Additional blood sticks will not be required to obtain this sample.
Interventions
- DEVICE PC/SMART cardiopulmonary bypass circuit
- DEVICE PMEA modified cardiopulmonary bypass circuit
- DEVICE Standard of care uncoated cardiopulmonary bypass circuit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2003-05 |
| Est. Completion | 2005-06 |
| Phase | NA |
What the finished NCT00208728 record still lists
NCT00208728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 3 interventions - of which PC/SMART cardiopulmonary bypass circuit is the first listed.
NCT00208728 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00208728 about?
NCT00208728 is a clinical study titled "Cardiopulmonary Circuits in the Pediatric Population". 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 blood caused by protein in the blood cell sticking to the sides of the heart-lung machine tubing. This...
What is the current status of trial NCT00208728?
This trial is currently completed. It is a NA study. The enrollment target is 90 participants. The study started on 2003-05. Estimated completion is 2005-06.
What interventions are being tested in trial NCT00208728?
The interventions under investigation include: PC/SMART cardiopulmonary bypass circuit (DEVICE), PMEA modified cardiopulmonary bypass circuit (DEVICE), Standard of care uncoated cardiopulmonary bypass circuit (DEVICE).
Who is sponsoring clinical trial NCT00208728?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00208728's enrollment target sits among peer trials
90 941st of 2000 higher than 1,029 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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