Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
NCT ID:
NCT00165906
Eligibility Criteria:
Inclusion Criteria:
1. 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)
2. Patients within the appropriate age group, i.e. less than 1 month old
3. Parents or legal guardian willing for the child to participate and able to sign the provided informed consent -
Exclusion Criteria:
1. Patients undergoing any emergent procedure/surgery
2. Patients who are being administered preoperative anticoagulant therapy
3. Patients with a known coagulation defect or coagulopathy
4. Patients who are premature, i.e. less than 37 weeks gestational age
5. Patient who are greater than 1 month of age
6. 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
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
30 Days
Study:
NCT00165906
Study Brief:
Protocol Section:
NCT00165906