Catheter InfectionNCT03725293
Midlines and Thrombophlebitis
A study testing Angiodynamics BioFlo Midline Catheter and Teleflex Arrowg+ard Blue Advanced Midline Catheter in people with Catheter Infection and Catheter Thrombosis, run by Corewell Health East at 1 site in United States.
Trial summary
Peripherally inserted central catheters (PICCs) are central catheters that are placed via peripheral vein under ultrasound guidance and may be used for patients with difficult venous access for long-term central or peripheral infusion therapies as well as central venous pressure monitoring in a critical care setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter Infection, Catheter Thrombosis, Catheter Complications
- What is being tested?
- Angiodynamics BioFlo Midline Catheter and Teleflex Arrowg+ard Blue Advanced Midline Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2019to 26 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All inpatients 18 years of age and older
- Inpatients that require midline catheter placement by the bedside vascular access team
Who cannot join
- Do not meet inclusion criteria
- Multiple lumens required
- Alternative diameter of catheter used
- If already enrolled once prior
- Withdraw voluntarily from the study
- Actively (within 24 hours) taking a therapeutic dose of an anticoagulant (heparin, low molecular weight heparin, enoxaparin, rivaroxaban, apixaban, dabigatran, edoxaban, warfarin, arixtra, factor Xa inhibitors)
- Receiving a midline catheter for anticoagulant therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073
About this study
Official title: Randomized Comparative Evaluation of Midline Catheters for Thrombophlebitis
Peripherally inserted central catheters (PICCs) are central catheters that are placed via peripheral vein under ultrasound guidance and may be used for patients with difficult venous access for long-term central or peripheral infusion therapies as well as central venous pressure monitoring in a critical care setting. Although PICCs provide a great option for some patients, these catheters have known complications including catheter-related bloodstream infection, catheter-related venous thrombosis or clotting, malfunction, and high cost. Midline catheters represent a potentially attractive alternative to PICCs for peripheral infusions. As midlines have increased in popularity and new midlines have been introduced into the market, it is necessary to better understand complication profiles of various midline catheters, as it is likely that all catheters are not created equal. Specifically, the incidence of symptomatic catheter-related thrombosis is of interest. Some midline catheters are coated to provide protection against catheter-related venous thrombosis and/or catheter-related bloodstream infection. The theoretical benefit(s) of these catheters need further validation in human subjects.
Read the detailed description
Study Design
The investigators propose a prospective single-site, parallel, two-arm, randomized investigation to assess catheter-related symptomatic upper extremity venous thrombosis (CR-UEVT), catheter-related bloodstream infection, and functionality of two single lumen midline catheters: AngioDynamics BioFlo 4 F and Teleflex Arrowg+ard Blue Advance 4.5 F.
Research staff of Beaumont Health Institute will allocate two midline catheters to eligible participants according to a pre-generated randomized list at a 1:1 ratio in block randomization to AngioDynamics BioFlo or Tele-flex Arrowg+ard Blue Advanced midline catheters. Participant enrollment will take place from November 2018 until recruitment of 250 participants, 125 in each group, is complete. Demographic and health-related information will be obtained from electronic medical records during enrolled period at William Beaumont Hospital.
Practitioner Participation/Training
Advanced Practice Providers within the bedside PICC/Midline service at the Royal Oak campus are eligible to place catheters for this study. All investigators are credentialed in placing PICCs and midlines by institutional policy and have greater than one year of experience in these procedures.
Initial Assessment
Post-cannulation and post securement, functionality is confirmed with blood sampling (10 cc) and flush without resistance.
The research team also will document practitioner details, the vascular access device (VAD) used, the time of VAD placement, number of attempts, need for a rescue inserter, the vein that was cannulated, depth and diameter of the vein, and the indication for VAD placement. An attempt is defined as each time the needle punctures the skin. Data will be collected from the electronic medical record and includes: age, gender, body mass index (BMI), vital signs, relevant past medical history. Indication for catheter placement will also be recorded.
Follow-up Assessment
Investigators will perform a follow-up assessment on all catheters within 24 hours of insertion and then daily for the life of the VAD. At each follow-up interval, the researcher will document the time of evaluation and assessment of functionality as well as review the patient chart for signs and symptoms of catheter-related bloodstream infection. If the catheter was identified to have failed during follow-up assessment the date and time of failure and the reason for failure will be documented. For all failed catheters, re-insertion attempt data will be tracked through the medical record.
Superficial venous thrombosis (SVT) and deep venous thrombosis (DVT) rates will be calculated based on upper extremity proven diagnosis of SVT and/or DVT in symptomatic cases. Radiology interpretations will be reviewed for findings consistent with CR-UEVT.
Infection rate will be tracked using confirmed catheter-related blood stream infection data from the surveillance team within the epidemiology department. The team utilizes the CDC definition of laboratory-confirmed blood-stream infection (LCBSI).
The medication administration record will be queried for all medications given through each catheter.
- Being tested
- Angiodynamics BioFlo Midline Catheter, Teleflex Arrowg+ard Blue Advanced Midline Catheter
- Keywords
- thrombosis, superficial venous thrombosis, deep venous thrombosis, line related infection, catheter survival
- Medical subject headings
- Thrombosis, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiodynamics BioFlo Midline CatheterDevice
Placement of Angiodynamics BioFlo Midline Catheter.
Teleflex Arrowg+ard Blue Advanced Midline CatheterDevice
Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter.
| Study group | Role | What they receive |
|---|---|---|
| Angiodynamics BioFlo Midline Catheter | Active comparator | Placement of clinically indicated Angiodynamics BioFlo midline catheter. Receives: Device: Angiodynamics BioFlo Midline Catheter |
| Teleflex Arrowg+ard Blue Advanced Midline Catheter | Active comparator | Placement of clinically indicated Teleflex Arrowg+ard Blue Advanced Midline Catheter Receives: Device: Teleflex Arrowg+ard Blue Advanced Midline Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity CR-UEVT
Number of participants with proven sonographic diagnosis of DVT and/or SVT
Measured: 30 days post line insertion
Secondary outcomes (1)
Line Related Infection
Number of participants with catheter related laboratory confirmed bloodstream infection per Centers for Disease Control (CDC) guidelines
Measured: 30 days post line insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start14 Jan 2019
- Primary completion26 Nov 2020
- Study completion26 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Catheter InfectionStudies 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
- Model description
- Prospective single-site, parallel, two-arm, randomized investigation
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Collaborators
- Teleflex
- Responsible party
- Principal investigator, Amit Bahl, Corewell Health East
- Investigators
- Amit Bahl, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725293
- Sponsor's protocol ID
- 2018-379
- Status last verified
- Jan 2022
- First submitted
- 25 Oct 2018
- Last updated
- 14 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bahl A, Johnson S, Mielke N, Chen NW. Risk Factors for Coated Midline Catheter-Related Thrombosis: A Secondary Analysis of Existing Trial Data. J Infus Nurs. 2023 Sep-Oct 01;46(5):259-265. doi: 10.1097/NAN.0000000000000518.
PubMed 37611283Bahl A, Diloreto E, Jankowski D, Hijazi M, Chen NW. Comparison of 2 Midline Catheter Devices With Differing Antithrombogenic Mechanisms for Catheter-Related Thrombosis: A Randomized Clinical Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2127836. doi: 10.1001/jamanetworkopen.2021.27836.
PubMed 34613402
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparative Evaluation of Midline Catheters for Thrombophlebitis
- ClinicalTrials.gov ID
- NCT03725293
- Acronym / sponsor ID
- 2018-379
- Keywords
- thrombosis, superficial venous thrombosis, deep venous thrombosis, line related infection, catheter survival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Collaborators
- Teleflex
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 26 Nov 2020 (actual)
- Study completion
- 26 Nov 2020 (actual)
- First posted
- 31 Oct 2018 (actual)
- Results
- Posted 14 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peripherally inserted central catheters (PICCs) are central catheters that are placed via peripheral vein under ultrasound guidance and may be used for patients with difficult venous access for long-term central or peripheral infusion therapies as well as central venous pressure monitoring in a critical care setting. Although PICCs provide a great option for some patients, these catheters have known complications including catheter-related bloodstream infection, catheter-related venous thrombosis or clotting, malfunction, and high cost. Midline catheters represent a potentially attractive alternative to PICCs for peripheral infusions. As midlines have increased in popularity and new midlines have been introduced into the market, it is necessary to better understand complication profiles of various midline catheters, as it is likely that all catheters are not created equal. Specifically, the incidence of symptomatic catheter-related thrombosis is of interest. Some midline catheters are coated to provide protection against catheter-related venous thrombosis and/or catheter-related bloodstream infection. The theoretical benefit(s) of these catheters need further validation in human subjects.
Detailed description
Study Design
The investigators propose a prospective single-site, parallel, two-arm, randomized investigation to assess catheter-related symptomatic upper extremity venous thrombosis (CR-UEVT), catheter-related bloodstream infection, and functionality of two single lumen midline catheters: AngioDynamics BioFlo 4 F and Teleflex Arrowg+ard Blue Advance 4.5 F.
Research staff of Beaumont Health Institute will allocate two midline catheters to eligible participants according to a pre-generated randomized list at a 1:1 ratio in block randomization to AngioDynamics BioFlo or Tele-flex Arrowg+ard Blue Advanced midline catheters. Participant enrollment will take place from November 2018 until recruitment of 250 participants, 125 in each group, is complete. Demographic and health-related information will be obtained from electronic medical records during enrolled period at William Beaumont Hospital.
Practitioner Participation/Training
Advanced Practice Providers within the bedside PICC/Midline service at the Royal Oak campus are eligible to place catheters for this study. All investigators are credentialed in placing PICCs and midlines by institutional policy and have greater than one year of experience in these procedures.
Initial Assessment
Post-cannulation and post securement, functionality is confirmed with blood sampling (10 cc) and flush without resistance.
The research team also will document practitioner details, the vascular access device (VAD) used, the time of VAD placement, number of attempts, need for a rescue inserter, the vein that was cannulated, depth and diameter of the vein, and the indication for VAD placement. An attempt is defined as each time the needle punctures the skin. Data will be collected from the electronic medical record and includes: age, gender, body mass index (BMI), vital signs, relevant past medical history. Indication for catheter placement will also be recorded.
Follow-up Assessment
Investigators will perform a follow-up assessment on all catheters within 24 hours of insertion and then daily for the life of the VAD. At each follow-up interval, the researcher will document the time of evaluation and assessment of functionality as well as review the patient chart for signs and symptoms of catheter-related bloodstream infection. If the catheter was identified to have failed during follow-up assessment the date and time of failure and the reason for failure will be documented. For all failed catheters, re-insertion attempt data will be tracked through the medical record.
Superficial venous thrombosis (SVT) and deep venous thrombosis (DVT) rates will be calculated based on upper extremity proven diagnosis of SVT and/or DVT in symptomatic cases. Radiology interpretations will be reviewed for findings consistent with CR-UEVT.
Infection rate will be tracked using confirmed catheter-related blood stream infection data from the surveillance team within the epidemiology department. The team utilizes the CDC definition of laboratory-confirmed blood-stream infection (LCBSI).
The medication administration record will be queried for all medications given through each catheter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective single-site, parallel, two-arm, randomized investigation
| Arm | Type | Receives |
|---|---|---|
| Angiodynamics BioFlo Midline Catheter | Active comparator | Device: Angiodynamics BioFlo Midline CatheterPlacement of clinically indicated Angiodynamics BioFlo midline catheter. |
| Teleflex Arrowg+ard Blue Advanced Midline Catheter | Active comparator | Device: Teleflex Arrowg+ard Blue Advanced Midline CatheterPlacement of clinically indicated Teleflex Arrowg+ard Blue Advanced Midline Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All inpatients 18 years of age and older
- Inpatients that require midline catheter placement by the bedside vascular access team
Key exclusion criteria (7 listed)
- Do not meet inclusion criteria
- Multiple lumens required
- Alternative diameter of catheter used
- If already enrolled once prior
- Withdraw voluntarily from the study
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 |
|---|---|---|
| Angiodynamics BioFlo Midline CatheterPlacement of Angiodynamics BioFlo Midline Catheter. | Device | Angiodynamics BioFlo Midline Catheter |
| Teleflex Arrowg+ard Blue Advanced Midline CatheterPlacement of Teleflex Arrowg+ard Blue Advanced Midline Catheter. | Device | Teleflex Arrowg+ard Blue Advanced Midline Catheter |
Primary outcome
Upper Extremity CR-UEVT
Time frame: 30 days post line insertion
Number of participants with proven sonographic diagnosis of DVT and/or SVT
1 secondary outcome
Line Related Infection
Time frame: 30 days post line insertion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37611283Bahl A, Johnson S, Mielke N, Chen NW. Risk Factors for Coated Midline Catheter-Related Thrombosis: A Secondary Analysis of Existing Trial Data. J Infus Nurs. 2023 Sep-Oct 01;46(5):259-265. doi: 10.1097/NAN.0000000000000518.
- Derived from this study: PubMed 34613402Bahl A, Diloreto E, Jankowski D, Hijazi M, Chen NW. Comparison of 2 Midline Catheter Devices With Differing Antithrombogenic Mechanisms for Catheter-Related Thrombosis: A Randomized Clinical Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2127836. doi: 10.1001/jamanetworkopen.2021.27836.
- Individual participant dataSharing planned: No
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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.
Amit Bahl, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angiodynamics BioFlo Midline Catheter and Teleflex Arrowg+ard Blue Advanced Midline Catheter in people with Catheter Infection and Catheter Thrombosis, run by Corewell Health East at 1 site in United States.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 14 Jan 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 14 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Upper Extremity CR-UEVT (time frame: 30 days post line insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03725293, which also lists 2 linked publications.
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 14 Jan 2022.