Use of Tetrasodium EDTA Catheter Lock Solution for Patients on HTPN (NCT04067245) | Clinical Trial Compass
UnknownNot Applicable
Use of Tetrasodium EDTA Catheter Lock Solution for Patients on HTPN
Canada20 participantsStarted 2019-04-01
Plain-language summary
Parenteral nutrition (PN) is a lifesaving therapy in patients with chronic intestinal failure. PN is administered via a central venous catheter (CVC), and patients are dependent on this line for ongoing nutrition. However, the presence of a CVC is associated with a risk of thrombosis and bloodstream infection. Many different types of catheter lock solutions have been used to mitigate these risks. They include solutions primarily aimed at reducing thrombosis, such as heparin and citrate, and others primarily aimed at reducing infection such as ethanol and antibiotics (for example, taurolidine). One recently developed solution, tetrasodium EDTA, aims to reduce both thrombosis and infection. This scientific review provides an overview of central venous catheter lock solutions, and an ease-of-use and cost analysis comparing heparin and tetrasodium EDTA in one home parenteral nutrition program in Toronto, Canada.
Who can participate
Age range
18 Years – 100 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:
* Adult over the age of 18
* Both males and females
* Clinically stable for at least 4 weeks with no acute medical co-morbidities
Exclusion Criteria:
* Inability to give informed consent
* Alcohol or drug abuse
* Pregnant and lactating women
* Clinical instability such as the following:
* Acute pulmonary edema
* Decompensated heart failure
* Decompensated chronic liver disease
* Severe post-traumatic conditions
* Uncontrolled diabetes mellitus
* Acute myocardial infarction
* Acute stroke
* Acute thromboembolism
* Metabolic acidosis
* Sepsis
* Hypotonic dehydration
* Coagulopathy with prolonged aPTT or INR
* Unstable oncology patient
* Subjects who are hypersensitive or allergic to the product ingredients of tetrasodium EDTA
* Active therapy with long-term anti-microbial, such as taurolidine (not including patients receiving intermitted antimicrobial treatment for small intestinal bacterial overgrowth)
* Active participation in another home TPN clinical trial which may interfere with the results
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.