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Transradial-Band Pilot Study

Primary Purpose

Radial Artery Incision Site Closure

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TR Band 60MIN
TR Band 120MIN
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Radial Artery Incision Site Closure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 al16.
  • 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.

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Outcomes

Primary Outcome Measures

Percentage of participants with significant hematomas
Hematoma >5 cm in size
Percentage of participants with significant hematomas
Hematoma >5 cm in size
Percentage of participants with bleeding
Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma
Percentage of participants with bleeding
Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma
Left radial artery occlusion
Reduced or absence of radial artery blood flow based on ultrasound and Barbeau test
Left radial artery occlusion
Reduced or absence of radial artery blood flow based on ultrasound and Barbeau test

Secondary Outcome Measures

Full Information

First Posted
January 12, 2021
Last Updated
February 21, 2023
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT04709341
Brief Title
Transradial-Band Pilot Study
Official Title
Optimization of Transradial-Band Removal Following Transradial Arterial Access for Interventional Radiology Diagnostic and Interventional Procedures (A Pilot Study)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 3, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radial Artery Incision Site Closure

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
TR Band 60MIN
Intervention Description
TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals
Intervention Type
Device
Intervention Name(s)
TR Band 120MIN
Intervention Description
TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals
Primary Outcome Measure Information:
Title
Percentage of participants with significant hematomas
Description
Hematoma >5 cm in size
Time Frame
an average of 12 hours post procedure
Title
Percentage of participants with significant hematomas
Description
Hematoma >5 cm in size
Time Frame
30 days post procedure
Title
Percentage of participants with bleeding
Description
Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma
Time Frame
an average of 12 hours post procedure
Title
Percentage of participants with bleeding
Description
Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma
Time Frame
30 days post procedure
Title
Left radial artery occlusion
Description
Reduced or absence of radial artery blood flow based on ultrasound and Barbeau test
Time Frame
an average of 12 hours post procedure
Title
Left radial artery occlusion
Description
Reduced or absence of radial artery blood flow based on ultrasound and Barbeau test
Time Frame
30 days post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 al16. 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.
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Transradial-Band Pilot Study

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