Cardiopulmonary Circuits in the Pediatric Population

Completed · Not applicable

Conditions studied: Pediatric, Cardiac Surgery

In brief

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.

Key facts

Study ID

NCT00208728

Run by

Emory University

People needed

90

Starts

2003-05-01

Expected to finish

2005-06-01

Last updated by the study team

2013-11-27

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• patients electively scheduled for first time cardiac surgery requiring cardiopulmonary bypass
• weight between 5 kg and 10 kg
• signed informed consent

You may not qualify if…

• 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.

Where it is running

• Children's Healthcare of Atlanta — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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