Heparin Responses in Pediatric Patients Undergoing Cardiopulmonary Bypass.
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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. |
| 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 |
Children undergoing elective cardiac surgery requiring the use of cardiopulmonary bypass
Inclusion Criteria:
- 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 -
Exclusion Criteria:
- 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
Contacts and Locations| United States, Georgia | |
| Children's Healthcare of Atlanta at Egleston | |
| Atlanta, Georgia, United States, 30322 | |
| Principal Investigator: | Nina A Guzzetta, MD | Emory University |
More Information
Publications:
| Responsible Party: | Nina Guzzetta, M.D., Assistant Professor of Anesthesiology, Emory University |
| ClinicalTrials.gov Identifier: | NCT00166140 History of Changes |
| Other Study ID Numbers: | 549-2002 |
| Study First Received: | September 12, 2005 |
| Last Updated: | March 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emory University:
|
pediatrics cardiac surgery |
ClinicalTrials.gov processed this record on May 22, 2013