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 (Kitelockâ„¢) 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 range3 Months – 18 Years
SexALL
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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
✕. Pregnancy or nursing mother
✕. 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
✕
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
✕. 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.