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Cardiopulmonary Circuits in the Pediatric Population

NCT00208728 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2013-11-27

No results posted yet for this 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.

Conditions

  • Pediatric
  • Cardiac Surgery

Interventions

DEVICE

PC/SMART cardiopulmonary bypass circuit

DEVICE

PMEA modified cardiopulmonary bypass circuit

DEVICE

Standard of care uncoated cardiopulmonary bypass circuit

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Paul Kirshbom, MD · Emory University and Children's Healthcare of Atlanta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31
Completion
2005-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00208728 on ClinicalTrials.gov