Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients (NCT04559334) | Clinical Trial Compass
SuspendedNot Applicable
Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
Stopped: There is a new randomized controlled study being coordinated at Cincinatti Children's Hospital (Paul Wales MD, Principal Investigator). Only patients enrolled in this compassionate use study can continue to participate and is closed to new patients.
United States15 participantsStarted 2020-12-21
Plain-language summary
In this research study we want to learn more about a study drug, tetrasodium sodium EDTA (Kitelock™) for maintaining the patency (blood flow) through a central venous catheter. Catheter occlusions such as blood clots have been shown to increase the risk of central line-associated bloodstream infection (CLABSI). This treatment consists of instilling a daily a dose of a solution , similar to heparin or saline lock flushes, into the catheter when it is not in use. The aim is to prevent CLABSI without increasing complications such as catheter breakage.
Who can participate
Age range
3 Months – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Patients aged 3 months to 18 years old inclusive
. Minimum patient weight of at least 5 kilograms
. History of at least one thrombolytic occlusion and/or CLABSI event
. Signed patient informed consent
. Clinically stable for at least 4 weeks with no acute medical co-morbidities
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Number of participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Timeframe: through study completion, an average of 1 year
2
The Number of Participants with Catheter Occlusions
Timeframe: through study completion, an average of 1 year
3
The Number of Participants with Catheter Breaks
Timeframe: through study completion, an average of 1 year
. Enrollment in any other clinical trial involving an investigational agent (unless approved by the principal investigators of the other trial)
. The parent or guardian or child unwilling to provide consent or assent
. Clinical instability such as the following:
. Subjects who are hypersensitive or allergic to EDTA
. Active therapy with long-term anti-microbial agents, such as taurolidine (not including patients receiving intermittent antimicrobial treatment for small intestinal bacterial overgrowth)
. A compromised catheter defined as one which has been repaired several times.