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:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT01330433
Eligibility Criteria:
Inclusion Criteria:
* Have an acceptable surrogate capable of giving consent on the subject's behalf.
* Pediatric patients ages 0 - 17
* Have a cardiac disease which requires staged cardiac surgery and resternotomy
* Non-emergent state or emergent state with sufficient time to educate and consent
Exclusion Criteria:
* An immune system disorder
* Unplanned reoperation
* Known hypersensitivity to components in CoSeal
* Patients undergoing reoperation less than 3 months after the primary surgery
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
17 Years
Study:
NCT01330433
Study Brief:
Protocol Section:
NCT01330433