Vascular Access DevicesMidLine_PICCNCT03502980
Safety and Efficacy of Midline and PICC
A study testing Bard PowerPICC and Bard PowerMidline catheter in people with Vascular Access Devices and Central Venous Catheter, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The purpose of this study is to assess the non-inferiority for safety and efficacy of using Midline in comparison with PICC for intravenous therapy that do not require a central catheter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Devices, Central Venous Catheter
- What is being tested?
- Bard PowerPICC and Bard PowerMidline catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2018to 21 Jul 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Required intra venous therapy
- Expected duration of the venous access: > 6 days and < 30days
Who cannot join
- Patient has a contraindication to insertion of either a Midline or a PICC relative to the therapy
- Patient from other hospitals who come to the CHUM only for the installation of a central line
- Decreased cognitive ability to care for device at home
- Preexisting bacteremia (ie, existing positive blood cultures that had not been repeated with negative results)
- Preexisting venous thrombosis or known hypercoagulable states (such as protein C or S deficiency, antithrombin deficiency, lupus anticoagulant)
- Venous access with multiple lumens required
Show all 11Show fewer
- Patients not able to give informed consent
- Prior participation to this study
- Patient is enrolled in another investigational study
- Patients hospitalized in the intensive care unit
- Patients who are difficult to puncture and require multiple blood samples
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier de l'université de Montréal
Montreal, Quebec, H2X 3E4
About this study
Official title: Safety and Efficacy of Midline and Peripherally Inserted Central Catheter for Intravenous Therapy: a Randomized Controlled Trial
The purpose of this study is to assess the non-inferiority for safety and efficacy of using Midline in comparison with PICC for intravenous therapy that do not require a central catheter.
Read the detailed description
Vascular access devices (VADs), including peripherally inserted central venous catheters (PICCs) remain a cornerstone for the delivery of necessary intravenous therapy. PICCs are being selected for venous access more frequently today than ever before.
The advantage of PICC is that it can be used for all intravenous therapy. However, PICC requires the use of fluoroscopy or other type of guidance which add to the cost and time required to insert the catheter. Midline, on the other hand, can be inserted under ultrasound guidance, takes less time to be inserted and cost less than PICC insertion.
Despite lower cost and better accessibility of midline in comparison with PICC for non-vesicant intravenous therapy, there is very little evidence in the literature to suggest that one type of venous access is better than the other.
The primary objective of this study is to assess the non-inferiority for safety and efficacy of using Midline in comparison with PICC for intravenous therapy that do not require a central catheter.
Results of this trial will allow improving a quality of evidence for using midline instead of PICC for specified indications. If Midline are non-inferior for some indications, they would represent a more accessible and less expensive alternative than PICC insertion.
- Conditions
- Vascular Access Devices, Central Venous Catheter
- Being tested
- Bard PowerPICC, Bard PowerMidline catheter
- Keywords
- Peripherally Inserted Central Catheter Line Insertion, Catheterization, Peripheral Venous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bard PowerPICCDevice
PICC Insertion
Bard PowerMidline catheterDevice
Midline Insertion
| Study group | Role | What they receive |
|---|---|---|
| Peripherally inserted central venous catheters | Active comparator | Bard PowerPICC Receives: Device: Bard PowerPICC |
| Midline | Active comparator | Bard PowerMidline catheter Receives: Device: Bard PowerMidline catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patients without VAD-related adverse event requiring medical intervention
Infections, Thrombophlebitis, Infiltration, Bleeding, Pain, Death
Measured: Until 1 week after VAD retrieval
% of patients whose intended or additional I.V treatments could be completed with the VAD without VAD complications, dysfunctions or limitations (ex: need for central access or for additional peripheral or central lumens/catheters)
Measured: Until 1 week after VAD retrieval
Secondary outcomes (8)
% of patients who experience VAD-related adverse events requiring medical intervention
Infections, Thrombophlebitis, Infiltration, Bleeding, Pain, Death
Measured: Until 1 week after VAD retrieval
Number of VAD-related adverse events requiring medical intervention per 1000 catheter/days
Measured: Until 1 week after VAD retrieval
Time to first VAD-related adverse events
Measured: Until 1 week after VAD retrieval
Duration VAD intervention (Midline or PICC)
Measured: Index procedure
Number of additional interventions to insert the VAD
Measured: Index procedure
% of patients who required another VAD to complete the intended or additional iv treatments, either because of VAD complications, dysfunctions or limitations
Measured: Until 1 week after VAD retrieval
% of patient without failed blood sampling attempts through the VAD
Measured: Until 1 week after VAD retrieval
% of patients for whom the end of treatment was the reason for VAD retrieval
Measured: Until 1 week after VAD retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start1 Jul 2018
- Primary completion21 Jul 2022
- Study completion21 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular Access DevicesStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Éric Thérasse, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502980
- Sponsor's protocol ID
- 7749
- Acronym
- MidLine_PICC
- Status last verified
- Aug 2021
- First submitted
- 9 Apr 2018
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bentridi A, Giroux MF, Soulez G, Bouchard L, Perreault P, Chouinard A, Dorais M, Do Amaral R, Bernier P, Therasse E. Midline Venous Catheter vs Peripherally Inserted Central Catheter for Intravenous Therapy: A Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e251258. doi: 10.1001/jamanetworkopen.2025.1258.
PubMed 40111366
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Midline and Peripherally Inserted Central Catheter for Intravenous Therapy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03502980
- Acronym / sponsor ID
- MidLine_PICC / 7749
- Conditions
- Vascular Access Devices, Central Venous Catheter
- Keywords
- Peripherally Inserted Central Catheter Line Insertion, Catheterization, Peripheral Venous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 21 Jul 2022 (actual)
- First posted
- 19 Apr 2018 (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.
The purpose of this study is to assess the non-inferiority for safety and efficacy of using Midline in comparison with PICC for intravenous therapy that do not require a central catheter.
Detailed description
Vascular access devices (VADs), including peripherally inserted central venous catheters (PICCs) remain a cornerstone for the delivery of necessary intravenous therapy. PICCs are being selected for venous access more frequently today than ever before.
The advantage of PICC is that it can be used for all intravenous therapy. However, PICC requires the use of fluoroscopy or other type of guidance which add to the cost and time required to insert the catheter. Midline, on the other hand, can be inserted under ultrasound guidance, takes less time to be inserted and cost less than PICC insertion.
Despite lower cost and better accessibility of midline in comparison with PICC for non-vesicant intravenous therapy, there is very little evidence in the literature to suggest that one type of venous access is better than the other.
The primary objective of this study is to assess the non-inferiority for safety and efficacy of using Midline in comparison with PICC for intravenous therapy that do not require a central catheter.
Results of this trial will allow improving a quality of evidence for using midline instead of PICC for specified indications. If Midline are non-inferior for some indications, they would represent a more accessible and less expensive alternative than PICC insertion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peripherally inserted central venous catheters | Active comparator | Device: Bard PowerPICCBard PowerPICC |
| Midline | Active comparator | Device: Bard PowerMidline catheterBard PowerMidline 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)
- Required intra venous therapy
- Expected duration of the venous access: > 6 days and < 30days
Key exclusion criteria (11 listed)
- Patient has a contraindication to insertion of either a Midline or a PICC relative to the therapy
- Patient from other hospitals who come to the CHUM only for the installation of a central line
- Decreased cognitive ability to care for device at home
- Preexisting bacteremia (ie, existing positive blood cultures that had not been repeated with negative results)
- Preexisting venous thrombosis or known hypercoagulable states (such as protein C or S deficiency, antithrombin deficiency, lupus anticoagulant)
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 |
|---|---|---|
| Bard PowerPICCPICC Insertion | Device | Peripherally inserted central venous catheters |
| Bard PowerMidline catheterMidline Insertion | Device | Midline |
Primary outcome
% of patients without VAD-related adverse event requiring medical intervention
Time frame: Until 1 week after VAD retrieval
Infections, Thrombophlebitis, Infiltration, Bleeding, Pain, Death
% of patients whose intended or additional I.V treatments could be completed with the VAD without VAD complications, dysfunctions or limitations (ex: need for central access or for additional peripheral or central lumens/catheters)
Time frame: Until 1 week after VAD retrieval
8 secondary outcomes
% of patients who experience VAD-related adverse events requiring medical intervention
Time frame: Until 1 week after VAD retrieval
Number of VAD-related adverse events requiring medical intervention per 1000 catheter/days
Time frame: Until 1 week after VAD retrieval
Time to first VAD-related adverse events
Time frame: Until 1 week after VAD retrieval
Duration VAD intervention (Midline or PICC)
Time frame: Index procedure
Number of additional interventions to insert the VAD
Time frame: Index procedure
% of patients who required another VAD to complete the intended or additional iv treatments, either because of VAD complications, dysfunctions or limitations
Time frame: Until 1 week after VAD retrieval
% of patient without failed blood sampling attempts through the VAD
Time frame: Until 1 week after VAD retrieval
% of patients for whom the end of treatment was the reason for VAD retrieval
Time frame: Until 1 week after VAD retrieval
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Derived from this study: PubMed 40111366Bentridi A, Giroux MF, Soulez G, Bouchard L, Perreault P, Chouinard A, Dorais M, Do Amaral R, Bernier P, Therasse E. Midline Venous Catheter vs Peripherally Inserted Central Catheter for Intravenous Therapy: A Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e251258. doi: 10.1001/jamanetworkopen.2025.1258.
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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.
Éric Thérasse, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bard PowerPICC and Bard PowerMidline catheter in people with Vascular Access Devices and Central Venous Catheter, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 11 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 25 Jul 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
% of patients without VAD-related adverse event requiring medical intervention (time frame: Until 1 week after VAD retrieval). The study lists 2 primary outcomes in all. 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 NCT03502980, which also lists 1 linked publication.
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 25 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.