Normal Saline Versus Heparinized Solution Flush for Maintaining Patency of Peripheral Venous Cath… (NCT01794767) | Clinical Trial Compass
SuspendedPhase 4
Normal Saline Versus Heparinized Solution Flush for Maintaining Patency of Peripheral Venous Catheters in Children
Stopped: difficult recruiting
Italy52 participantsStarted 2013-01
Plain-language summary
The aim of the study is to verify if the periodic flush with normal saline 0.9% NaCl causes a longer or equal duration of patency of peripheral venous catheters, compared with heparin solution 50 U / ml flush, in children from 2 years to 14 years. Only 22 and 24 gauge catheters Will be included in the study.The study will assess in particular:
* the difference of permanence in situ of the device
* the difference in incidence of complications (in detail: obstruction, phlebitis, thrombocytopenia, systemic anticoagulation)
* the difference in costs between use of saline normal saline 0.9% NaCl solution and heparinized 50 U / ml.
Who can participate
Age range
2 Years – 14 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:
* Age between 2 years and 14 years old
* Medical prescription of intravenous antibiotic therapy for at least 2 doses on the day
* Presence of informed consent to participate to the study provided by the parents
* No known hypersensitivity to heparin
* No known hypersensitivity to the patch fixing materials (polyurethane and / or glue)
* Absence of diseases buoyancy coagulation (haemophilias and / or thrombophilias)
* No antecedents trombopenie dued to the use of any type of heparin or a pentosan polysulfate
* No existing treatment based on corticosteroids and / or anti-inflammatory
Exclusion Criteria:
* age outside the range 2 - 14 years
* children for which there is no prescription of intravenous antibiotic therapy for at least 2 times a day
* children for which the parents have not consented to the study
* children with known hypersensitivity to heparin
* children with known hypersensitivity to the patch fixing materials (polyurethane and / or adhesive)
* children with disease-causing buoyancy coagulation (Hemophilia and / or thrombophilia)
* children with antecedents of trombopenie occurring by the use of any type of heparin or of a pentosan polyphosphate
* children in treatment with corticosteroids and / or anti-inflammatory
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
Average length of stay on site of the catheter measured in hours
Timeframe: participants will be followed for the duration on site of the first peripheral venous catheter inserted to each recruited subject, i.e. for an expected average of 10 dayse