Multi-Day Evaluation of the TIVA Device

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 Overview

• Status: Completed
• Conditions: Blood Collections Via Peripheral IV Catheter
• Intervention / Treatment: Device: TIVA blood collection device

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: A- Control; Group A will have their PIVs assessed daily and record kept of PIV dislodgement or replacement
Experimental: B - Device Intervention; 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	Device: TIVA 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Velano Vascular, Inc.
• Investigators: Principal Investigator: Deborah F Mulloy, PhD, RN, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2016
• Primary Completion (Actual): November 21, 2016
• Study Completion (Actual): December 7, 2016

Study Registration Dates

• First Submitted: April 14, 2016
• First Submitted That Met QC Criteria: April 20, 2016
• First Posted (Estimate): April 21, 2016

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CP-004