Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter

Stopped early · Not applicable

Conditions studied: Vascular Access Complication

In brief

The study will test a hypothesis that the RIVS system will have a higher rate of successful first PIV placement compared to conventional catheter without a significant increase in complications and time of procedure.

Key facts

Study ID

NCT00914069

Run by

C. R. Bard

People needed

175

Starts

2009-06-01

Expected to finish

2013-08-01

Last updated by the study team

2017-04-13

Who can join

Age: 5 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Any type of oncology patients undergoing chemotherapy or post-chemotherapy (without a port/cannula), or over 65 years
• Requires peripheral IV as determined by examining physician
• Requires the IV when a study nurse or resident is available
• Able to sign an informed consent

You may not qualify if…

• Active systemic or cutaneous infection or inflammation;
• Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
• Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count < 100,000 cells/mm3, baseline International Normalized Ratio (INR) ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);
• Currently involved in any other investigational clinical trials;
• Previous vascular grafts or surgery at the target vessel access site;
• Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
• Central line available
• Requirement for immediate IV placement (patient's condition would potentially be compromised if there is a time delay in IV placement)

Where it is running

• Washington Outpatient Surgery Center — Fremont, California, United States
• St. Vincent's Medical Center — Jacksonville, Florida, United States
• University Hospital Case Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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