Radial Artery Incision Site Closure Clinical Trial
Official title:
Optimization of Transradial-Band Removal Following Transradial Arterial Access for Interventional Radiology Diagnostic and Interventional Procedures (A Pilot Study)
| Verified date | February 2024 |
| Source | Medical University of South Carolina |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | February 20, 2024 |
| Est. primary completion date | February 1, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Medical University of South Carolina | Charleston | South Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of South Carolina |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of participants with significant hematomas | Hematoma >5 cm in size | an average of 12 hours post procedure | |
| Primary | Percentage of participants with significant hematomas | Hematoma >5 cm in size | 30 days post procedure | |
| Primary | Percentage of participants with bleeding | Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma | an average of 12 hours post procedure | |
| Primary | Percentage of participants with bleeding | Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma | 30 days post procedure | |
| Primary | Left radial artery occlusion | Reduced or absence of radial artery blood flow based on ultrasound and Barbeau test | an average of 12 hours post procedure | |
| Primary | Left radial artery occlusion | Reduced or absence of radial artery blood flow based on ultrasound and Barbeau test | 30 days post procedure |