Heparin Responses in Pediatric Patients Undergoing Cardiopulmonary Bypass.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nina Guzzetta, M.D., Emory University
ClinicalTrials.gov Identifier:
NCT00166140
First received: September 12, 2005
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

Heparin is an anticoagulant or "blood thinner". Heparin is always given to patients undergoing open-heart surgery to prevent blood from clotting when a patient is placed on the heart-lung machine. Heparin works by combining with a protein in blood to prevent other proteins from working together to form a clot. The protein that heparin combines with seems to be different in infants and young children compared to adults.

The purpose of this study is to determine which proteins in children have a direct impact on the way heparin works. We also want to see how this may change at different ages. We will enroll two age groups of children; birth to 2 years and 10 years or older. A total of 125 patients will be enrolled into this study. These patients will already be scheduled for open-heart surgery using a heart-lung machine.

The testing involves taking blood samples when the patient is asleep for surgery; and later from their intravenous line, IV. They will all have IV's in place already because of the surgery. Therefore the study will cause no pain or discomfort for the patients who take part.


Condition
Children With Heart Defects

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Heparin Responses in Pediatric Patients Undergoing Cardiopulmonary Bypass.

Resource links provided by NLM:


Further study details as provided by Emory University:

Estimated Enrollment: 125
Study Start Date: December 2002
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children undergoing elective cardiac surgery requiring the use of cardiopulmonary bypass

Criteria

Inclusion Criteria:

  1. Patients undergoing elective cardiac surgery requiring the use of cardiopulmonary bypass scheduled at Children's Healthcare of Atlanta, Egleston (either a first procedure or a reoperation)
  2. Patients within the appropriate age groups (birth to 2 years of age, and 10 years or older)
  3. Parents or legal guardian willing for child to participate and able to sign the provided informed consent -

Exclusion Criteria:

  1. Patients undergoing cardiac surgery not requiring the use of CPB
  2. Patients undergoing any emergent procedure/surgery
  3. Patients who take preoperative anticoagulant therapy
  4. Patients with a CPB time greater that 4 hours
  5. Patients requiring a return to CPB for any reason
  6. Patients whose parents or legal guardian are unwilling or unable to sign the provided informed consent
  7. Patients who, in the opinion of the investigators, should not be included in the study
  8. Patients who are older than 2 years, but less than 10 years of age are excluded
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166140

Locations
United States, Georgia
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Nina A Guzzetta, MD Emory University