Status:
COMPLETED
Thrombin Generation in Neonates
Lead Sponsor:
Emory University
Collaborating Sponsors:
Children's Healthcare of Atlanta
Conditions:
Blood Coagulation Disorders
Eligibility:
All Genders
Up to 30 years
Brief Summary
Children having open heart surgery must be on a heart-lung bypass machine. It is essential that the blood in the heart-lung machine does not clot. This is accomplished by giving a drug called heparin,...
Detailed Description
Neonates are unique due to maturational differences in their coagulation systems. During the first few months of life, distinct differences exist between the coagulation system of a neonate and that o...
Eligibility Criteria
Inclusion
- Patients undergoing elective cardiac surgery scheduled at Children's Healthcare of Atlanta as a first time procedure OR patients undergoing elective non-cardiac surgery scheduled at Children's Healthcare of Atlanta (control group)
- Patients within the appropriate age group, i.e. less than 1 month old
- Parents or legal guardian willing for the child to participate and able to sign the provided informed consent -
Exclusion
- Patients undergoing any emergent procedure/surgery
- Patients who are being administered preoperative anticoagulant therapy
- Patients with a known coagulation defect or coagulopathy
- Patients who are premature, i.e. less than 37 weeks gestational age
- Patient who are greater than 1 month of age
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00165906
Start Date
January 1 2005
End Date
January 1 2009
Last Update
November 21 2013
Active Locations (1)
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1
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322