NCT03502980

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
293

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 19, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2022

Completed
Last Updated

July 25, 2022

Status Verified

August 1, 2021

Enrollment Period

4.1 years

First QC Date

April 9, 2018

Last Update Submit

July 22, 2022

Conditions

Vascular Access DevicesCentral Venous Catheter

Keywords

Peripherally Inserted Central Catheter Line InsertionCatheterization, Peripheral Venous

Outcome Measures

Primary Outcomes (2)

  • % of patients without VAD-related adverse event requiring medical intervention

    Infections, Thrombophlebitis, Infiltration, Bleeding, Pain, Death

    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)

    Until 1 week after VAD retrieval

Secondary Outcomes (8)

  • % of patients who experience VAD-related adverse events requiring medical intervention

    Until 1 week after VAD retrieval

  • Number of VAD-related adverse events requiring medical intervention per 1000 catheter/days

    Until 1 week after VAD retrieval

  • Time to first VAD-related adverse events

    Until 1 week after VAD retrieval

  • Duration VAD intervention (Midline or PICC)

    Index procedure

  • Number of additional interventions to insert the VAD

    Index procedure

  • +3 more secondary outcomes

Study Arms (2)

Peripherally inserted central venous catheters

ACTIVE COMPARATOR

Bard PowerPICC

Device: Bard PowerPICC

Midline

ACTIVE COMPARATOR

Bard PowerMidline catheter

Device: Bard PowerMidline catheter

Interventions

Bard PowerPICCDEVICE

PICC Insertion

Peripherally inserted central venous catheters
Bard PowerMidline catheterDEVICE

Midline Insertion

Midline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Required intra venous therapy
  • Expected duration of the venous access: \> 6 days and \< 30days

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier de l'université de Montréal

Montreal, Quebec, H2X 3E4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 40111366DERIVED

Study Officials

  • Éric Thérasse, MD

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2018

First Posted

April 19, 2018

Study Start

July 1, 2018

Primary Completion

July 21, 2022

Study Completion

July 21, 2022

Last Updated

July 25, 2022

Record last verified: 2021-08

Locations

CA(1)