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Midlines and Thrombophlebitis

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ClinicalTrials.gov Identifier: NCT03725293
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
Teleflex
Information provided by (Responsible Party):
Amit Bahl, William Beaumont Hospitals

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Catheter Infection Catheter Thrombosis Catheter Complications Device: Angiodynamics BioFlo Midline Catheter Device: Teleflex Arrowg+ard Blue Advanced Midline Catheter Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective single-site, parallel, two-arm, randomized investigation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Comparative Evaluation of Midline Catheters for Thrombophlebitis
Actual Study Start Date : January 14, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arm Intervention/treatment
Active Comparator: Angiodynamics BioFlo Midline Catheter
Placement of clinically indicated Angiodynamics BioFlo midline catheter.
Device: Angiodynamics BioFlo Midline Catheter
Placement of Angiodynamics BioFlo Midline Catheter.

Active Comparator: Teleflex Arrowg+ard Blue Advanced Midline Catheter
Placement of clinically indicated Teleflex Arrowg+ard Blue Advanced Midline Catheter
Device: Teleflex Arrowg+ard Blue Advanced Midline Catheter
Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter.




Primary Outcome Measures :
  1. Upper extremity CR-UEVT [ Time Frame: 30 days post line insertion ]
    Number of participants with proven sonographic diagnosis of DVT and/or SVT


Secondary Outcome Measures :
  1. Line related infection [ Time Frame: 30 days post line insertion ]
    Number of participants with catheter related laboratory confirmed bloodstream infection per Centers for Disease Control (CDC) guidelines


Other Outcome Measures:
  1. Catheter Survival [ Time Frame: 30 days post line insertion ]
    Time to catheter failure in hours as demonstrated by inability to flush catheter with 5 mL of normal saline without resistance.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All inpatients 18 years of age and older
  • Inpatients that require midline catheter placement by the bedside vascular access team

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03725293


Contacts
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Contact: Amit Bahl, MD 2482290736 amit.bahl@beaumont.edu
Contact: Mara Branoff, RN 2488989111 mara.branoff@beaumont.org

Locations
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United States, Michigan
Beaumont Hospital - Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Teleflex
Investigators
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Principal Investigator: Amit Bahl, MD William Beaumont Hospitals

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Responsible Party: Amit Bahl, Director, Emergency Ultrasound, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT03725293     History of Changes
Other Study ID Numbers: 2018-379
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Amit Bahl, William Beaumont Hospitals:
thrombosis
superficial venous thrombosis
deep venous thrombosis
line related infection
catheter survival
Additional relevant MeSH terms:
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Thrombosis
Thrombophlebitis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Thrombosis
Phlebitis
Peripheral Vascular Diseases
Vasculitis