Blood Collections Via Peripheral IV Catheter
Conditions
Brief summary
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.
Interventions
DEVICETIVA blood collection 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
Sponsors
Velano Vascular, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient will be admitted to the BWH unit 15 for post-surgical care * Patient is at least 18 years old * Patient is willing and physically / cognitively able to sign a written consent form * Patient is willing and able to complete study questionnaires * Patient is NOT a prisoner
Exclusion criteria
* Active hemodialysis * Hemolytic disorders (e.g., sickle cell disease) * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % Aspiration reliability | up to 4 days after PIV placement | blood aspiration with the device is attempted once per day. The % of attempts that are successful will be reported across all attempts |
| % of Specimen hemolyzed | up to 4 days | each collected specimen will be analyzed for hemolysis. The hemolysis rate, or % of specimen that are hemolyzed will be reported over all collections. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Avg PIV dwell - hours, mean, range | 1, 2, 3, and 4 calendar days after PIV placement | note hours between each PIV placement and removal for each patient. compare the the distribution of PIV dwell between the two arms |
Countries
United States
Outcome results
None listed