Midlines and Thrombophlebitis

NCT ID: NCT03725293

Last Updated: 2022-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-14
• Study Completion Date: 2020-11-26

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.

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.

Conditions

Catheter Infection; Catheter Thrombosis; Catheter Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Angiodynamics BioFlo Midline Catheter

Placement of clinically indicated Angiodynamics BioFlo midline catheter.

Group Type: ACTIVE_COMPARATOR

Angiodynamics BioFlo Midline Catheter

Intervention Type: DEVICE

Placement of Angiodynamics BioFlo Midline Catheter.

Teleflex Arrowg+ard Blue Advanced Midline Catheter

Placement of clinically indicated Teleflex Arrowg+ard Blue Advanced Midline Catheter

Group Type: ACTIVE_COMPARATOR

Teleflex Arrowg+ard Blue Advanced Midline Catheter

Intervention Type: DEVICE

Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter.

Interventions

Angiodynamics BioFlo Midline Catheter

Placement of Angiodynamics BioFlo Midline Catheter.

Intervention Type: DEVICE

Teleflex Arrowg+ard Blue Advanced Midline Catheter

Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teleflex

INDUSTRY

Sponsor Role: collaborator

William Beaumont Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Amit Bahl

Director, Emergency Ultrasound

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amit Bahl, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

Beaumont Hospital - Royal Oak

Royal Oak, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37611283 (View on PubMed)

Bahl 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.

Reference Type: DERIVED

PMID: 34613402 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018-379

Identifier Type: -

Identifier Source: org_study_id