Clinical trial NCT03725293: Midlines and Thrombophlebitis
Official title: Randomized Comparative Evaluation of Midline Catheters for Thrombophlebitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter Infection
Catheter Thrombosis
Catheter Complications
Keywords: thrombosis
superficial venous thrombosis
deep venous thrombosis
line related infection
catheter survival
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: Teleflex
First posted: 2018-10-31
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective single-site, parallel, two-arm, randomized investigation
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Upper Extremity CR-UEVT
timeFrame: 30 days post line insertion
Secondary outcomes:
measure: Line Related Infection
timeFrame: 30 days post line insertion
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Hospital - Royal Oak
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Amit Bahl, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.