Heparinization vs Salinization of the Peripheral Venous Catheter (NCT05209841) | Clinical Trial Compass
RecruitingNot Applicable
Heparinization vs Salinization of the Peripheral Venous Catheter
Spain3,450 participantsStarted 2022-04-05
Plain-language summary
Randomized, double-blind clinical trial to compare the efficacy of catheter sealing with saline, compared to low-dose heparin. 3,450 patients hospitalized at the Hospital Residencia Sant Camil, in Catalonia (Spain), will be randomized to each branch of study. The primary outcome will be the percentage of catheters removed due to obstruction in each branch of study. As secondary outcomes, the number of catheter-associated phlebitis, catheter-associated bacetrihemia, extravasation, and catheter loss will be measured. For the primary outcome, a superiority analysis will be carried out in terms of the percentage of obstructed catheters in each branch of the study.
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:
* Patients older than 18 yo, admitted to the Hospital Residencia Sant Camil
* Patients with at least one peripheral venous line for discontinuous treatment, which has not been channeled in a medical emergency situation.
* Written informed consent
Exclusion Criteria:
* Allergy to heparin
* Patients treated with unfractionated sodium heparin.
* Patients in dialysis
* Patients with a venous catheter indicated for diagnosis tests.
* Patients with a venous catheter indicated for blood transfusion
* Severe heparin-induced thrombocytopenia in recent months
* Active uncontrollable bleeding during admission
* Brain aneurysm or dissecting aorta, except in association with corrective surgery.
* Confirmed / suspected cerebrovascular hemorrhage
* Severe uncontrolled hypertension
* Severe alterations in platelet coagulation \<30,000, TP\> 1.7 APTT ratio\> 1.7 ratio.
* Patient included in another clinical trial with drugs or procedures that may affect the patency of venous catheters.
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
Percentage of obstructed catheters
Timeframe: From date of randomization through the date of hospital discharge, an average of 10 days.
Trial details
NCT IDNCT05209841
SponsorConsorci Sanitari de l'Alt Penedès i Garraf