Cardiopulmonary Circuits in the Pediatric Population

NCT00208728 | Completed

• 1 other identifier: 0227-2003
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pediatric; Cardiac Surgery

Keywords

pediatric; congenital heart disease; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Decrease in platelet activation, platelet sequestration and fibrinolysis.

Secondary Outcomes (1)

• Decrease in post-operative coagulopathy as measured by bleeding and blood product use.

Interventions

PC/SMART cardiopulmonary bypass circuit DEVICE

PMEA modified cardiopulmonary bypass circuit DEVICE

Standard of care uncoated cardiopulmonary bypass circuit DEVICE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Related Publications (5)

• 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.

  PMID: 8507971 BACKGROUND

• 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.

  PMID: 11156123 BACKGROUND

• 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.

  PMID: 12238845 BACKGROUND

• 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.

  PMID: 9594864 BACKGROUND

• 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.

  PMID: 8431082 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Paul Kirshbom, MD

  Emory University and Children's Healthcare of Atlanta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: May 1, 2003
• Study Completion: June 1, 2005
• Last Updated: November 27, 2013

Record last verified: 2013-11

Locations

US (1)