Trial Outcomes & Findings for Midlines and Thrombophlebitis (NCT NCT03725293)

NCT ID: NCT03725293

Last Updated: 2022-01-14

Results Overview

Number of participants with proven sonographic diagnosis of DVT and/or SVT

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 212 participants
• Primary outcome timeframe: 30 days post line insertion
• Results posted on: 2022-01-14

Participant Flow

Participant milestones

Measure	Angiodynamics BioFlo Midline Catheter Placement of clinically indicated Angiodynamics BioFlo midline catheter. Angiodynamics BioFlo Midline Catheter: Placement of Angiodynamics BioFlo Midline Catheter.	Teleflex Arrowg+Ard Blue Advanced Midline Catheter Placement of clinically indicated Teleflex Arrowg+ard Blue Advanced Midline Catheter Teleflex Arrowg+ard Blue Advanced Midline Catheter: Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter.
Overall Study STARTED	106	106
Overall Study COMPLETED	94	97
Overall Study NOT COMPLETED	12	9

Reasons for withdrawal

Measure	Angiodynamics BioFlo Midline Catheter Placement of clinically indicated Angiodynamics BioFlo midline catheter. Angiodynamics BioFlo Midline Catheter: Placement of Angiodynamics BioFlo Midline Catheter.	Teleflex Arrowg+Ard Blue Advanced Midline Catheter Placement of clinically indicated Teleflex Arrowg+ard Blue Advanced Midline Catheter Teleflex Arrowg+ard Blue Advanced Midline Catheter: Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter.
Overall Study Physician Decision	9	6
Overall Study alternative vascular access needs	1	2
Overall Study venous anatomy screen failures	2	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Angiodynamics BioFlo Midline Catheter n=94 Participants Placement of clinically indicated Angiodynamics BioFlo midline catheter. Angiodynamics BioFlo Midline Catheter: Placement of Angiodynamics BioFlo Midline Catheter.	Teleflex Arrowg+Ard Blue Advanced Midline Catheter n=97 Participants Placement of clinically indicated Teleflex Arrowg+ard Blue Advanced Midline Catheter Teleflex Arrowg+ard Blue Advanced Midline Catheter: Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter.	Total n=191 Participants Total of all reporting groups
Age, Continuous	60.29 years STANDARD_DEVIATION 16.3 • n=94 Participants	59.5 years STANDARD_DEVIATION 17.1 • n=97 Participants	60.2 years STANDARD_DEVIATION 16.7 • n=191 Participants
Sex: Female, Male Female	54 Participants n=94 Participants	60 Participants n=97 Participants	114 Participants n=191 Participants
Sex: Female, Male Male	40 Participants n=94 Participants	37 Participants n=97 Participants	77 Participants n=191 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	94 Participants n=94 Participants	97 Participants n=97 Participants	191 Participants n=191 Participants

PRIMARY outcome

Timeframe: 30 days post line insertion

Number of participants with proven sonographic diagnosis of DVT and/or SVT

Outcome measures

Measure	Angiodynamics BioFlo Midline Catheter n=94 Participants Placement of clinically indicated Angiodynamics BioFlo midline catheter. Angiodynamics BioFlo Midline Catheter: Placement of Angiodynamics BioFlo Midline Catheter.	Teleflex Arrowg+Ard Blue Advanced Midline Catheter n=97 Participants Placement of clinically indicated Teleflex Arrowg+ard Blue Advanced Midline Catheter Teleflex Arrowg+ard Blue Advanced Midline Catheter: Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter.
Upper Extremity CR-UEVT	7 Participants	11 Participants

SECONDARY outcome

Timeframe: 30 days post line insertion

Number of participants with catheter related laboratory confirmed bloodstream infection per Centers for Disease Control (CDC) guidelines

Outcome measures

Measure	Angiodynamics BioFlo Midline Catheter n=94 Participants Placement of clinically indicated Angiodynamics BioFlo midline catheter. Angiodynamics BioFlo Midline Catheter: Placement of Angiodynamics BioFlo Midline Catheter.	Teleflex Arrowg+Ard Blue Advanced Midline Catheter n=97 Participants Placement of clinically indicated Teleflex Arrowg+ard Blue Advanced Midline Catheter Teleflex Arrowg+ard Blue Advanced Midline Catheter: Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter.
Line Related Infection	0 Participants	0 Participants

Adverse Events

Angiodynamics BioFlo Midline Catheter

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Teleflex Arrowg+Ard Blue Advanced Midline Catheter

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Angiodynamics BioFlo Midline Catheter n=94 participants at risk Placement of clinically indicated Angiodynamics BioFlo midline catheter. Angiodynamics BioFlo Midline Catheter: Placement of Angiodynamics BioFlo Midline Catheter.	Teleflex Arrowg+Ard Blue Advanced Midline Catheter n=97 participants at risk Placement of clinically indicated Teleflex Arrowg+ard Blue Advanced Midline Catheter Teleflex Arrowg+ard Blue Advanced Midline Catheter: Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter.
Blood and lymphatic system disorders Pulmonary Embolism	1.1% 1/94 • Number of events 1 • 30 days post line insertion	0.00% 0/97 • 30 days post line insertion

Other adverse events

Measure	Angiodynamics BioFlo Midline Catheter n=94 participants at risk Placement of clinically indicated Angiodynamics BioFlo midline catheter. Angiodynamics BioFlo Midline Catheter: Placement of Angiodynamics BioFlo Midline Catheter.	Teleflex Arrowg+Ard Blue Advanced Midline Catheter n=97 participants at risk Placement of clinically indicated Teleflex Arrowg+ard Blue Advanced Midline Catheter Teleflex Arrowg+ard Blue Advanced Midline Catheter: Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter.
Blood and lymphatic system disorders Catheter Failure	23.4% 22/94 • 30 days post line insertion	20.6% 20/97 • 30 days post line insertion

Additional Information

Amit Bahl, MD

Beaumont Hospitals

Phone: (248) 898-9111

Email: ahmit.bahl@beaumont.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place