Study Results
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View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2021-02-03
2024-02-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Group A
TR Band 60MIN
TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals
Group B
TR Band 120MIN
TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals
Interventions
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TR Band 60MIN
TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals
TR Band 120MIN
TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Medical University of South Carolina
OTHER
Responsible Party
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Locations
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Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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00088481
Identifier Type: -
Identifier Source: org_study_id
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