Multi-Day Evaluation of the TIVA Device

V

Velano Vascular

Status

Completed

Conditions

Blood Collections Via Peripheral IV Catheter

Treatments

Device: TIVA blood collection device

Study type

Interventional

Funder types

Industry

Identifiers

NCT02747147
CP-004

Details and patient eligibility

About

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.

Enrollment

160 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

160 participants in 2 patient groups

A- Control
No Intervention group
Description:
Group A will have their PIVs assessed daily and record kept of PIV dislodgement or replacement
B - Device Intervention
Experimental group
Description:
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
Treatment:
Device: TIVA blood collection device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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