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 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT04559334
Eligibility Criteria:
Inclusion Criteria:
1. Presence of a tunneled central venous catheter or peripherally inserted central catheter (PICC) for administration of PN or intravenous hydration fluids to treat intestinal failure
2. Patients aged 3 months to 18 years old inclusive
3. Minimum patient weight of at least 5 kilograms
4. History of at least one thrombolytic occlusion and/or CLABSI event
5. Signed patient informed consent
6. Clinically stable for at least 4 weeks with no acute medical co-morbidities
Exclusion Criteria:
1. Pregnancy or nursing mother
2. Enrollment in any other clinical trial involving an investigational agent (unless approved by the principal investigators of the other trial)
3. The parent or guardian or child unwilling to provide consent or assent
4. Clinical instability such as the following:
* Acute pulmonary edema
* Acute myocardial infarction
* Acute stroke
* Acute thromboembolism
* Metabolic acidosis
* Sepsis
* Coagulopathy with prolonged activated partial thromboplastin time (aPTT) or international normalized ratio (INR)
* Severe hypoglycemia
5. Subjects who are hypersensitive or allergic to EDTA
6. Active therapy with long-term anti-microbial agents, such as taurolidine (not including patients receiving intermittent antimicrobial treatment for small intestinal bacterial overgrowth)
7. A compromised catheter defined as one which has been repaired several times.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
18 Years
Study:
NCT04559334
Study Brief:
Protocol Section:
NCT04559334