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OpenTrials
Completed

NCT Number: NCT02747147

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.

Completed

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Key information

Conditions

Blood Collections Via Peripheral IV Catheter

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. % Aspiration reliability

    Time frame: 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

  2. % of Specimen hemolyzed

    Time frame: 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 outcomes

  1. Avg PIV dwell - hours, mean, range

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Velano Vascular, Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 21, 2016
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.