Status:
COMPLETED
Transradial-Band Pilot Study
Lead Sponsor:
Medical University of South Carolina
Conditions:
Radial Artery Incision Site Closure
Eligibility:
All Genders
18+ years
Phase:
NA
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 6...
Eligibility Criteria
Inclusion
- 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 al16.
- INR less than 1.5
- Platelet count greater than 50,000 platelet/uL
- Prothrombin time less than 15 seconds
Exclusion
- 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.
Key Trial Info
Start Date :
February 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04709341
Start Date
February 3 2021
End Date
February 20 2024
Last Update
April 6 2025
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425