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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TR Band 60MIN | Device | TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Left Radial Artery Occlusion | Reduced or absence of radial artery blood flow based on ultrasound and Barbeau test | 30 days post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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No significant events, such as washout or run-in periods, occurred after participant enrollment and before group assignment. All participants who met eligibility criteria, including acceptable Barbeau test results, ultrasound evaluation, and coagulation parameters, were randomized directly into the expedited or standard protocol groups. No exclusions were reported after enrollment and prior to randomization
The study was conducted at MUSC's VIR Department, including University Hospital and outpatient clinics. Patients scheduled for angiographic procedures were screened for eligibility via Barbeau tests, ultrasounds, and lab reviews. Informed consent was obtained during consultations or in recovery bays. Recruitment involved 30 randomized patients divided into expedited and standard protocol groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The baseline analysis population included 30 patients randomized into expedited (n=15) and standard (n=15) protocol groups. All participants met inclusion criteria: age >18 years, Barbeau test types A-C, radial artery diameter ≥1.6 mm, and acceptable coagulation parameters (platelet count >50,000/µL, INR <1.5, PT <15s). No significant differences in demographics or clinical characteristics were observed between groups
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Bleeding | Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma | Posted | Count of Participants | Participants | an average of 12 hours post procedure |
|
30 days
The outcomes focus on safety, efficacy, and complications specific to the radial artery access site, and no deaths were mentioned or attributed to the procedures or protocols
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Bruising | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samuel Bidwell- Research Manager | Medical University of South Carolina | 843-792-2305 | bidwells@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 28, 2022 | Dec 6, 2024 | Prot_SAP_000.pdf |
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| TR Band 120MIN | Device | TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Percentage of Participants With Bleeding | Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma | Posted | Count of Participants | Participants | 30 days post procedure |
|
|
|
| Primary | Left Radial Artery Occlusion | Reduced or absence of radial artery blood flow based on ultrasound and Barbeau test | No patients presented with this symptom during the TR Band Procedure. | Posted | Count of Participants | Participants | 30 days post procedure |
|
|
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| 0 |
| 15 |
| 0 |
| 15 |
| 1 |
| 15 |
| EG001 | 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 | 0 | 15 | 0 | 15 | 0 | 15 |
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