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| ID | Type | Description | Link |
|---|---|---|---|
| 1291856 | Other Identifier | WIRB |
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| Name | Class |
|---|---|
| Northwell Health | OTHER |
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Clinical randomized study to evaluate the effect of using a hydrophobically modified polysaccharide (hm-P) bandage
The study will evaluate the clinical performance (e.g. hemostatic and patient outcomes) of this hm-P bandage by using an earlier time for removal of the bandage (e.g. 60 minutes) than the current standard of care (e.g. 90-180 minutes) while also reducing the inflated pressure of the band, and hence the compressive force put on the wrist of the patient, in increments of the % of inflation as per current protocol, with N=20 @ 100%, N=20 @ 75%, & N=20 @ 50%. This study will be completed while maintaining vascular integrity and patency through visualization in patients undergoing angiographic procedures via anticoagulated, percutaneous radial arterial cannulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full Inflation | Other | 100% TR Band inflation relative to recommended inflation with 15-18 cc air injected in TR band bladder |
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| Mid Inflation | Other | 75% TR Band inflation relative to recommended inflation with 11-14 cc air injected in TR band bladder |
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| Low Inflation | Other | 50% TR Band inflation relative to recommended inflation with 8-9 cc air injected in TR band bladder |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hm-P bandage | Device | hm-P bandage will be placed over the puncture site with the TR band positioned over the hemostatic bandage. The TR band will then be inflated per device specific instructions and to the group instructions. The arterial sheath will be removed from the body with slight device rotation. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to hemostasis | Significant change in time to hemostasis | 60 minutes |
| Compressive Force | Change in the compressive force onto the access site | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Radial Artery | Evaluation of the radial artery post hemostasis by visual or reverse Barbeau test | immediately after hemostasis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Varinder Singh, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lenox Hill Hospital - Northwell Health | New York | New York | 10075 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 2, 2022 | May 27, 2022 | 3 |
60 patients, randomized into one of three arms
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