Intravenous AccessNCT06727240
Safe-Infusion Study
A study testing Intervention in people with Intravenous Access and Medical Device, run by Interlinked AB at 2 sites in 2 countries.
Trial summary
Around 1.5 billion peripheral intravenous catheters (PIVCs) are sold yearly, with up to 90% of hospitalized patients receiving one, yet failure rates can reach 69%, often due to phlebitis, infiltration, occlusion, or dislodgement. These complications can collectively be named mechanical complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intravenous Access, Medical Device
- What is being tested?
- Intervention
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 548 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Mar 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has or will get a vascular access device (VAD) expected to be used for continuous or intermittent IV infusion therapy. Continuous IV infusion is defined as an infusion ≥2h and intermitted as an infusion lasting 15min to <2h.
- ≥18 years of age
- Speak and understand local language
- VADs already in place when the patient is admitted to the ward should not present with phlebitis or infiltration or occlusion
- Participants have signed the informed consent or have a legal authorized representative (LAR) who has provided this consent
Who cannot join
- The VAD is expected to be used for sampling only
- Pregnancy
- Unable to obtain informed consent or without an available LAR to provide surrogate informed consent
- Patients under palliative care
- Bolus IV infusion, defined as an infusion time of <15 min
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Portugal1 site, 1 recruiting
- Recruiting
Centro Hospitalar e Universitário de Coimbra
Coimbra, 3000-075
PI, +351 239 400 400, amarques@chuc.min-saude.pt
About this study
Official title: A Non-Inferiority Randomized Clinical Trial Investigating Efficacy and Safety of an Innovative Medical Device in the Reduction of Mechanical Complications of Peripheral Intravenous Catheters
Around 1.5 billion peripheral intravenous catheters (PIVCs) are sold yearly, with up to 90% of hospitalized patients receiving one, yet failure rates can reach 69%, often due to phlebitis, infiltration, occlusion, or dislodgement. These complications can collectively be named mechanical complications. This study aims to assess a new device's effectiveness in reducing mechanical complications associated with PIVCs through a non-inferiority randomized trial at two sites. A total of 548 patients will be recruited, with primary outcomes focused on complication rates and secondary outcomes examining adverse events, healthcare feedback, and economic impacts.
Read the detailed description
It is estimated that around 1.5 billion PIVC are sold yearly throughout the globe, and placing them is one of the most common invasive procedures in hospitalised patients, with up to 90% receiving one, yet there is a failure rate of up to 69%.1-5 Some of the most common causes of failure are considered to be phlebitis, subcutaneous infiltration, occlusion and dislodgement. These failure rates vary widely throughout the globe, where published data suggests rates of 8-44% for phlebitis, 5-21% for infiltration, 7.6-16% for occlusion and 5-10% for dislodgement.4,6-12 Phlebitis, commonly defined as an inflammatory process in the wall of a vein, resulting in a blood clot formation; while infiltration is defined as the inadvertent leakage of a solution into the surrounding tissue; occlusion is defined as catheter failure due to blockage, and dislodgement the accidental/ in adverted removal of the PIVC before intended.13 Previous studies have suggested that mechanical irritation could be an important factor resulting in PIVC failure.14-16 In the case of phlebitis, mechanical movements against the endothelial wall could initiate a cascade of prothrombotic events resulting in the formation of a blood clot, something that has been demonstrated in a simulated environment.14,17,18 Furthermore micromechanical movements of the PIVC could eventually lead the PIVC to migrate from within the vessel wall to be unintentionally placed outside the vessel, yet, still in the surrounding tissue causing infiltration. Occlusion is the sudden block of the PIVC, where flushing or aspirating from the PIVC is not possible. Dislodgement of a PIVC is the act of mechanical movement of the PIVC from the intravascular space to the surrounding environment outside of the body.
Therefore, there is a need to investigate potential new methods for prevention of these mechanical complications, and one method could be in the reduction of mechanical forces acting on the vessels. The aim of this study is to investigate the safety and effectiveness of a new medical device in reducing the number of mechanical complications during IV therapy.
To answer this aim, a non-inferiority randomized clinical trial will be executed at two sites, where patients having a vascular access will be examined in a systematic fashion. Inclusion criteria are: having VAD, >18 years of age, speak local language, absence of signs of phlebitis or infiltration, and a signed consent form. Exclusion criteria are: VAD for sampling only, pregnancy, unable to obtain informed consent, patients under palliative care and VAD for bolus infusion only.
A total of 548 patients will be recruited to this study, and it is estimated to take 5 months to complete. The primary outcomes/endpoints are to investigate the rate of mechanical complications in the form of phlebitis, infiltration, occlusion and dislodgement. While secondary outcomes/endpoints will be identifying the frequency and severity of any adverse events, healthcare opinions on the device and the economic burden of the mechanical complications. No follow up is planned in this trial.
- Conditions
- Intravenous Access, Medical Device
- Being tested
- Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionDevice
The interventional device is a coupling device intended to prevent mechanical complications during peripheral intravenous infusions. While control will not receive the device.
| Study group | Role | What they receive |
|---|---|---|
| ReLink® | Experimental | One or more investigational devices will be added to the infusion line. Standard practise procedure related to PIVC infusions according to hospital norm will be followed. Thereafter the planned IV therapy is initiated until completion. Receives: Device: Intervention |
| Control | No intervention | Standard practise related to PIVC infusions according to hospital norm will be followed. Thereafter the planned IV therapy is initiated until completion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of mechanical complications of an IV therapy session using the device compared to using current 'state of the art'.
Mechanical complications are defied as following:
- Phlebitis -inflammation of a vein based on clinical diagnosis
- Infiltration - the process of accidental leakage of fluids out of the veins into peripheral tissue
- Occlusion - blocked PIVC, where flushing or aspirating from the PIVC is not possible
- Dislodgment - the process of accidental/ unintentional complete removal of the PIVC before scheduled removal
Measured: Baseline PIVC data and immediatly after PIVC removal
Secondary outcomes (3)
Frequency and severity of any adverse events
Measured: Through study participation (hospitlized in the ward), an average of 5 days
Healthcare workers opinion of investigational device
A questionnaire has been developed asking baseline data from healthcare worker. The questionnaire contains questions about 1) opinion about using the device again, 2) recommendation of the device, and 3) usage of the device for a relative. Each question is ranked from 0 to 5.
Measured: Immediately after the intervention
The economic cost of these disruptions to your facility in terms of man-hours, and resources.
Measured: Immediatly after PIVC removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start25 Mar 2024
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravenous AccessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 548 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Interlinked AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parc Sanitari Sant Joan de Déu, Unidade Local de Saúde de Coimbra, EPE
- Responsible party
- Sponsor
- Investigators
- Ramon Mir Abellán, PhD, Principal investigator, Parc Sanitari Sant Joan de DéuAntónio Manuel Marques, PhD, Principal investigator, Unidade Local de Saúde de Coimbra, EPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727240
- Sponsor's protocol ID
- Interlinked 05-01-11
- Status last verified
- Dec 2024
- First submitted
- 29 Nov 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All research results will be reported at a de-identified level, and any statistical correlations linked to personal data in terms of gender and/or age will be reported at an aggregated level.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Inferiority Randomized Clinical Trial Investigating Efficacy and Safety of an Innovative Medical Device in the Reduction of Mechanical Complications of Peripheral Intravenous Catheters
- ClinicalTrials.gov ID
- NCT06727240
- Acronym / sponsor ID
- Interlinked 05-01-11
- Conditions
- Intravenous Access, Medical Device
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 548 participants (estimated)
- Lead sponsor
- Interlinked ABIndustry (pharma, biotech, devices)
- Collaborators
- Parc Sanitari Sant Joan de Déu, Unidade Local de Saúde de Coimbra, EPE
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 10 Dec 2024 (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.
Around 1.5 billion peripheral intravenous catheters (PIVCs) are sold yearly, with up to 90% of hospitalized patients receiving one, yet failure rates can reach 69%, often due to phlebitis, infiltration, occlusion, or dislodgement. These complications can collectively be named mechanical complications. This study aims to assess a new device's effectiveness in reducing mechanical complications associated with PIVCs through a non-inferiority randomized trial at two sites. A total of 548 patients will be recruited, with primary outcomes focused on complication rates and secondary outcomes examining adverse events, healthcare feedback, and economic impacts.
Detailed description
It is estimated that around 1.5 billion PIVC are sold yearly throughout the globe, and placing them is one of the most common invasive procedures in hospitalised patients, with up to 90% receiving one, yet there is a failure rate of up to 69%.1-5 Some of the most common causes of failure are considered to be phlebitis, subcutaneous infiltration, occlusion and dislodgement. These failure rates vary widely throughout the globe, where published data suggests rates of 8-44% for phlebitis, 5-21% for infiltration, 7.6-16% for occlusion and 5-10% for dislodgement.4,6-12 Phlebitis, commonly defined as an inflammatory process in the wall of a vein, resulting in a blood clot formation; while infiltration is defined as the inadvertent leakage of a solution into the surrounding tissue; occlusion is defined as catheter failure due to blockage, and dislodgement the accidental/ in adverted removal of the PIVC before intended.13 Previous studies have suggested that mechanical irritation could be an important factor resulting in PIVC failure.14-16 In the case of phlebitis, mechanical movements against the endothelial wall could initiate a cascade of prothrombotic events resulting in the formation of a blood clot, something that has been demonstrated in a simulated environment.14,17,18 Furthermore micromechanical movements of the PIVC could eventually lead the PIVC to migrate from within the vessel wall to be unintentionally placed outside the vessel, yet, still in the surrounding tissue causing infiltration. Occlusion is the sudden block of the PIVC, where flushing or aspirating from the PIVC is not possible. Dislodgement of a PIVC is the act of mechanical movement of the PIVC from the intravascular space to the surrounding environment outside of the body.
Therefore, there is a need to investigate potential new methods for prevention of these mechanical complications, and one method could be in the reduction of mechanical forces acting on the vessels. The aim of this study is to investigate the safety and effectiveness of a new medical device in reducing the number of mechanical complications during IV therapy.
To answer this aim, a non-inferiority randomized clinical trial will be executed at two sites, where patients having a vascular access will be examined in a systematic fashion. Inclusion criteria are: having VAD, >18 years of age, speak local language, absence of signs of phlebitis or infiltration, and a signed consent form. Exclusion criteria are: VAD for sampling only, pregnancy, unable to obtain informed consent, patients under palliative care and VAD for bolus infusion only.
A total of 548 patients will be recruited to this study, and it is estimated to take 5 months to complete. The primary outcomes/endpoints are to investigate the rate of mechanical complications in the form of phlebitis, infiltration, occlusion and dislodgement. While secondary outcomes/endpoints will be identifying the frequency and severity of any adverse events, healthcare opinions on the device and the economic burden of the mechanical complications. No follow up is planned in this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ReLink® | Experimental | Device: InterventionOne or more investigational devices will be added to the infusion line. Standard practise procedure related to PIVC infusions according to hospital norm will be followed. Thereafter the planned IV therapy is initiated until completion. |
| Control | No intervention | –Standard practise related to PIVC infusions according to hospital norm will be followed. Thereafter the planned IV therapy is initiated until completion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient has or will get a vascular access device (VAD) expected to be used for continuous or intermittent IV infusion therapy. Continuous IV infusion is defined as an infusion ≥2h and intermitted as an infusion lasting 15min to <2h.
- ≥18 years of age
- Speak and understand local language
- VADs already in place when the patient is admitted to the ward should not present with phlebitis or infiltration or occlusion
- Participants have signed the informed consent or have a legal authorized representative (LAR) who has provided this consent
Key exclusion criteria (5 listed)
- The VAD is expected to be used for sampling only
- Pregnancy
- Unable to obtain informed consent or without an available LAR to provide surrogate informed consent
- Patients under palliative care
- Bolus IV infusion, defined as an infusion time of <15 min
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 |
|---|---|---|
| InterventionThe interventional device is a coupling device intended to prevent mechanical complications during peripheral intravenous infusions. While control will not receive the device. | Device | ReLink® |
Primary outcome
The rate of mechanical complications of an IV therapy session using the device compared to using current 'state of the art'.
Time frame: Baseline PIVC data and immediatly after PIVC removal
Mechanical complications are defied as following: * Phlebitis -inflammation of a vein based on clinical diagnosis * Infiltration - the process of accidental leakage of fluids out of the veins into peripheral tissue * Occlusion - blocked PIVC, where flushing or aspirating from the PIVC is not possible * Dislodgment - the process of accidental/ unintentional complete removal of the PIVC before scheduled removal
3 secondary outcomes
Frequency and severity of any adverse events
Time frame: Through study participation (hospitlized in the ward), an average of 5 days
Healthcare workers opinion of investigational device
Time frame: Immediately after the intervention
The economic cost of these disruptions to your facility in terms of man-hours, and resources.
Time frame: Immediatly after PIVC removal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: Yes. All research results will be reported at a de-identified level, and any statistical correlations linked to personal data in terms of gender and/or age will be reported at an aggregated level.
Related trials for Intravenous Access
Enrolling by invitation
TruVascular Access - Ultrasound-Guided Vascular Access Study
Peripheral Venous Catheterization, Difficult Intravenous Access
Recruiting
Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses
Difficult Vein Access, Emergency Department Patients
Active, not recruitingObservational study
A New Landmark-formula for Cephalic Vein in Children
Venipuncture, Ultrasound
Recruiting
Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters: SpadCare Experience
Infusions, Intravenous, Administration, Intravenous
Not yet recruiting
Ultra-Long Peripheral Catheter Versus Accelerated Seldinger Technique Long Peripheral Catheter in Difficult IV Access Patients
Difficult Intravenous Access, Adults
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.
Ramon Mir Abellán, PhD principal investigator
Parc Sanitari Sant Joan de Déu
António Manuel Marques, PhD principal investigator
Unidade Local de Saúde de Coimbra, EPE
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Intravenous Access and Medical Device, run by Interlinked AB at 2 sites in 2 countries.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Blacker, Medical Doctor (+46737301399, christopher.blacker@uu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of mechanical complications of an IV therapy session using the device compared to using current 'state of the art'. (time frame: Baseline PIVC data and immediatly after PIVC removal). 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 16 Dec 2024; AzTrials last refreshed its copy on 28 Oct 2026.