Catheter ComplicationsNCT05209841
Heparinization vs Salinization of the Peripheral Venous Catheter
A study testing Low dose heparin and Normal saline in people with Catheter Complications, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Catheter Complications
- What is being tested?
- Low dose heparin and Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 289 participants
- Where
- 1 siteSpain
- Study dates
- 5 Apr 2022to 10 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heparinization vs Salinization of the Peripheral Venous Catheter: a Randomized Clinical Trial
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.
- Conditions
- Catheter Complications
- Being tested
- Low dose heparin, Normal saline
- Keywords
- Catheterization, Peripheral, Catheter Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose heparinDrug
Catheters will be sealed with 3 mL of Fibrillin Ⓡ (heparin 20UI/mL)
Normal salineDrug
Catheters will be sealed with 3mL of 0.9% sodium chloride
| Study group | Role | What they receive |
|---|---|---|
| Catheter sealing with low dose heparin | Experimental | Catheters will be sealed with 3mL of Fibrillin Ⓡ (heparin 20UI/mL) Receives: Drug: Low dose heparin |
| Catheter sealing with normal saline | Active comparator | Catheters will be sealed with 3mL of 0.9% sodium chloride Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of obstructed catheters
percentage of obstructed catheters
Measured: From date of randomization through the date of hospital discharge, an average of 10 days.
Secondary outcomes (3)
Number of catheter-associated phlebitis
Number of catheter-associated phlebitis
Measured: From date of randomization through the date of hospital discharge, an average of 10 days.
Number of catheter-associated bacterihemia episodes
Number of catheter-associated bacterihemia episodes
Measured: From date of randomization through the date of hospital discharge, an average of 10 days.
Number of catheter loss due to extravasation
Number of catheter loss due to extravasation
Measured: From date of randomization through the date of hospital discharge, an average of 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start5 Apr 2022
- Primary completion10 Jul 2025
- Study completion10 Jul 2025
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esther Moreno Rubio, Principal investigator, CSAPG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209841
- Sponsor's protocol ID
- CSAPG-18
- Status last verified
- Oct 2026
- First submitted
- 29 Dec 2021
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research proposels and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heparinization vs Salinization of the Peripheral Venous Catheter: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05209841
- Acronym / sponsor ID
- CSAPG-18
- Conditions
- Catheter Complications
- Keywords
- Catheterization, Peripheral, Catheter Obstruction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter sealing with low dose heparin | Experimental | Drug: Low dose heparinCatheters will be sealed with 3mL of Fibrillin Ⓡ (heparin 20UI/mL) |
| Catheter sealing with normal saline | Active comparator | Drug: Normal salineCatheters will be sealed with 3mL of 0.9% sodium chloride |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose heparinCatheters will be sealed with 3 mL of Fibrillin Ⓡ (heparin 20UI/mL) | Drug | Catheter sealing with low dose heparin |
| Normal salineCatheters will be sealed with 3mL of 0.9% sodium chloride | Drug | Catheter sealing with normal saline |
Primary outcome
Percentage of obstructed catheters
Time frame: From date of randomization through the date of hospital discharge, an average of 10 days.
percentage of obstructed catheters
3 secondary outcomes
Number of catheter-associated phlebitis
Time frame: From date of randomization through the date of hospital discharge, an average of 10 days.
Number of catheter-associated bacterihemia episodes
Time frame: From date of randomization through the date of hospital discharge, an average of 10 days.
Number of catheter loss due to extravasation
Time frame: From date of randomization through the date of hospital discharge, an average of 10 days.
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Yes. IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research proposels and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Moreno Rubio principal investigator
CSAPG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose heparin and Normal saline in people with Catheter Complications, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of obstructed catheters (time frame: From date of randomization through the date of hospital discharge, an average of 10 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.