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 @ 2:11 PM
Ignite Modification Date:
2025-12-24 @ 2:11 PM
NCT ID:
NCT02685995
Eligibility Criteria:
Inclusion Criteria:
* End stage renal disease or acute renal failure requiring hemodialysis through a tunneled dialysis catheter
* Age \>18, Age \<80
* Capable of giving informed consent
Exclusion Criteria:
* Coagulopathy defined as international normalized ration (INR) \>2 which cannot be corrected with fresh frozen plasma
* Platelet count \<50,000/microliter, which cannot be corrected with platelet transfusion
* Active skin infections at site of TDC insertion
* Presence of bacteremia or infected AVG/AVF within 7 days prior to enrollment
* Neutropenia defined as absolute neutrophil count less then 1,700/microliter
* Known central venous stenosis
* Occlusion of bilateral external and internal jugular veins or bilateral brachiocephalic veins or stenosis of the superior vena cava
* Functioning surgical HD access (ie AVG/AVF) or AVG/AVF which is expected to be functional within 90 days of enrollment
* Inability to provide informed consent
* Pregnant or nursing women
* In the event a physician does not feel that either catheter would be appropriate for a subject, the subject will not be eligible to participate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02685995
Study Brief:
Protocol Section:
NCT02685995