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Prospective, randomized, single-center study to evaluate the ability of the device to collect good quality blood samples from patients with peripheral IV access over the length of their stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A- Control | No Intervention | Group A will have their PIVs assessed daily and record kept of PIV dislodgement or replacement | |
| B - Device Intervention | Experimental | patients will have their PIVs assessed daily and record kept of PIV displodgement or replacement. patients will additionally have a single blood collection attempted using the study device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIVA blood collection device | Device | the device is attached to a peripheral IV catheter for use as a direct blood draw device into a vacuum tube or a syringe |
|
| Measure | Description | Time Frame |
|---|---|---|
| % Aspiration reliability | blood aspiration with the device is attempted once per day. The % of attempts that are successful will be reported across all attempts | up to 4 days after PIV placement |
| % of Specimen hemolyzed | each collected specimen will be analyzed for hemolysis. The hemolysis rate, or % of specimen that are hemolyzed will be reported over all collections. | up to 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Avg PIV dwell - hours, mean, range | note hours between each PIV placement and removal for each patient. compare the the distribution of PIV dwell between the two arms | 1, 2, 3, and 4 calendar days after PIV placement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah F Mulloy, PhD, RN | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 30, 2018 | |
| Reset | May 29, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 30, 2018 | May 29, 2018 |
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