Status:
TERMINATED
Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter
Lead Sponsor:
C. R. Bard
Conditions:
Vascular Access Complication
Eligibility:
All Genders
5-90 years
Phase:
NA
Brief Summary
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 ti...
Detailed Description
The hypothesis to be statistically tested was that the RIVS system will have a higher rate of successful first attempt peripheral intravenous placement success as compared to conventional peripheral i...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- Exclusion Criteria
- 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)
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT00914069
Start Date
June 1 2009
End Date
August 1 2013
Last Update
April 13 2017
Active Locations (3)
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1
Washington Outpatient Surgery Center
Fremont, California, United States, 94538
2
St. Vincent's Medical Center
Jacksonville, Florida, United States, 32204
3
University Hospital Case Medical Center
Cleveland, Ohio, United States, 44106