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:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2025-12-24 @ 4:48 PM
NCT ID:
NCT01171950
Eligibility Criteria:
Inclusion Criteria:
1. Age 5 years to 16 years, inclusive
2. Inability to wean from cardiopulmonary bypass (CPB)
Exclusion Criteria:
1. Body weight \< 20 kg
2. Severe aortic insufficiency
3. Unrestricted intra-cardiac communications (i.e. large VSD)
4. Pulmonary vascular resistance index (PVRI) \> 10 IU
5. Presence of DIC
6. On hemodialysis (excluding hemofiltration)
7. Contraindications to systemic anticoagulation
8. Active systemic infection unresponsive to antibiotics
9. Unresolved malignancy
10. On other investigational VAS
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
16 Years
Study:
NCT01171950
Study Brief:
Protocol Section:
NCT01171950