NCT04709341CompletedNot Applicable
Optimization of Transradial-Band Removal Following Transradial Arterial Access for Interventional Radiology Diagnostic and Interventional Procedures (A Pilot Study)
Medical University of South Carolina2 sites in 1 country30 target enrollmentStarted: February 3, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Percentage of Participants With Bleeding
Study Overview
Brief Summary
In the study group, the TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals. In the standard of care group, the TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals. The aim of the study is to reduce the time the device is in place while minimizing potential complications.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years and older
- •Have an acceptable Barbeau test (i.e. type A through C)
- •Have acceptable coagulation parameters (based on PT, INR, platelet count, and appropriate pre-procedural management of anticoagulants, See Table 1)
- •The caliber of the left radial artery based on a pre-procedure sonographic evaluation will need to be greater than or equal to 1.6 mm.
- •The appropriate pre-procedural management of anticoagulants is based on the consensus guidelines established by Patel et al
- •INR less than 1.5
- •Platelet count greater than 50,000 platelet/uL
- •Prothrombin time less than 15 seconds
Exclusion Criteria
- •If there is an unacceptable risk of bleeding diathesis, or
- •If he or she is not a suitable candidate for transradial access based on a Barbeau test type D or a diameter of the left radial artery less than 1.6 mm.
Outcomes
Primary Outcomes
Percentage of Participants With Bleeding
Time Frame: 30 days post procedure
Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma
Left Radial Artery Occlusion
Time Frame: 30 days post procedure
Reduced or absence of radial artery blood flow based on ultrasound and Barbeau test
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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