Heparin Responses in Pediatric Patients Undergoing Cardiopulmonary Bypass.

Completed

Conditions studied: Children With Heart Defects

In brief

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.

Key facts

Study ID

NCT00166140

Run by

Emory University

People needed

125

Starts

2002-12-01

Expected to finish

2006-05-01

Last updated by the study team

2013-11-20

Who can join

Age: any, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• Patients within the appropriate age groups (birth to 2 years of age, and 10 years or older)
• Parents or legal guardian willing for child to participate and able to sign the provided informed consent -

You may not qualify if…

• Patients undergoing cardiac surgery not requiring the use of CPB
• Patients undergoing any emergent procedure/surgery
• Patients who take preoperative anticoagulant therapy
• Patients with a CPB time greater that 4 hours
• Patients requiring a return to CPB for any reason
• Patients whose parents or legal guardian are unwilling or unable to sign the provided informed consent
• Patients who, in the opinion of the investigators, should not be included in the study
• Patients who are older than 2 years, but less than 10 years of age are excluded

Where it is running

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

Full record on ClinicalTrials.gov

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