Multi-Day Evaluation of the TIVA Device

Velano Vascular, Inc.160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

160

Conditions

Blood Collections Via Peripheral IV Catheter

Interventions

TIVA blood collection deviceDEVICE

the device is attached to a peripheral IV catheter for use as a direct blood draw device into a vacuum tube or a syringe

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

% Aspiration reliability

blood aspiration with the device is attempted once per day. The % of attempts that are successful will be reported across all attempts

Time frame: 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.

Time frame: up to 4 days

Secondary Outcomes

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

Time frame: 1, 2, 3, and 4 calendar days after PIV placement

Data from ClinicalTrials.gov

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