Midlines and Thrombophlebitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03725293|
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : September 26, 2019
|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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective single-site, parallel, two-arm, randomized investigation|
|Masking:||None (Open Label)|
|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|
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.
- Upper extremity CR-UEVT [ Time Frame: 30 days post line insertion ]Number of participants with proven sonographic diagnosis of DVT and/or SVT
- 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
- 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.
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
|Contact: Amit Bahl, MDemail@example.com|
|Contact: Mara Branoff, RNfirstname.lastname@example.org|
|United States, Michigan|
|Beaumont Hospital - Royal Oak||Recruiting|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Amit Bahl, MD||William Beaumont Hospitals|