NCT00208728|Completed
Cardiopulmonary Circuits in the Pediatric Population
Prospective Evaluation of Modified Cardiopulmonary Bypass Circuits in the Pediatric Population
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Prospective Evaluation of Modified Cardiopulmonary Bypass Circuits in the Pediatric Population
Sponsor study identifier
interventional
90
1 country
1
Study Start
May 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2003
Date type not reportedThis date has not been verified as actual or estimated.
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
September 13, 2005
Actual (reported)September 21, 2005
Actual (reported)Decrease in platelet activation, platelet sequestration and fibrinolysis.
Decrease in post-operative coagulopathy as measured by bleeding and blood product use.
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Edmunds LH Jr. Blood-surface interactions during cardiopulmonary bypass. J Card Surg. 1993 May;8(3):404-10. doi: 10.1111/j.1540-8191.1993.tb00384.x.
Defraigne JO, Pincemail J, Dekoster G, Larbuisson R, Dujardin M, Blaffart F, David JL, Limet R. SMA circuits reduce platelet consumption and platelet factor release during cardiac surgery. Ann Thorac Surg. 2000 Dec;70(6):2075-81. doi: 10.1016/s0003-4975(00)01838-5.
Paul Kirshbom, MD
Emory University and Children's Healthcare of Atlanta
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
May 2003
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
June 2005
LiDCO Monitor Study
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Gunaydin S, Farsak B, Kocakulak M, Sari T, Yorgancioglu C, Zorlutuna Y. Clinical performance and biocompatibility of poly(2-methoxyethylacrylate)-coated extracorporeal circuits. Ann Thorac Surg. 2002 Sep;74(3):819-24. doi: 10.1016/s0003-4975(02)03796-7.
Gu YJ, Boonstra PW, Rijnsburger AA, Haan J, van Oeveren W. Cardiopulmonary bypass circuit treated with surface-modifying additives: a clinical evaluation of blood compatibility. Ann Thorac Surg. 1998 May;65(5):1342-7. doi: 10.1016/s0003-4975(98)00223-9.
Butler J, Rocker GM, Westaby S. Inflammatory response to cardiopulmonary bypass. Ann Thorac Surg. 1993 Feb;55(2):552-9. doi: 10.1016/0003-4975(93)91048-r.
This date has not been verified as actual or estimated.
Last Updated
November 27, 2013
Record last verified: 2013-11
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