NCT03996135

Brief Summary

The objective of this study is to evaluate the effectiveness of AccuVein AV400 to facilitate placement of peripheral intravenous catheters in cirrhotic adults by comparing the success rate of the first attempt to install a peripheral venous catheter with or without AccuVein AV400®.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 24, 2019

Completed
12 months until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

August 24, 2022

Status Verified

July 1, 2022

Enrollment Period

3 years

First QC Date

June 5, 2019

Last Update Submit

August 23, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • First Attempt Success Rate of Cannulation

    Firt attempt success of positional for each peripheral venous catheter and expressed as a percentage in cirrhotic patients during hospitalization.

    baseline

Secondary Outcomes (6)

  • change of the score A-DIVA

    baseline and end of hospitalization (up to a month)

  • Cost

    baseline

  • Life expectancy of the catheter

    baseline

  • Utilisation of a central venous catheter

    baseline

  • Pain's score

    baseline

  • +1 more secondary outcomes

Study Arms (2)

Experimental : Cannulation with AccuVein AV400

EXPERIMENTAL

Cirrhotic patients benefit from the support of a venous illumination device for each peripheral venous cannulation

Device: Cannulation with AccuVein AV400

Control

NO INTERVENTION

Cirrhotic patients benefit from the standard technique of peripheral veinous catheter placement.

Interventions

Cannulation using AccuVein AV400 device

Also known as: AccuVein AV400
Experimental : Cannulation with AccuVein AV400

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient older than 18 years old
  • Patient presenting a liver cirrhosis
  • Patient requiring the placement of a venous peripheral catheter
  • Patient informed and giving free and informed consent
  • Patient affiliated to a French social security scheme

You may not qualify if:

  • Patient under 18 years old
  • Patient unable to give consent
  • Patient under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, 14033, France

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Catheterization

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Central Study Contacts

Philippe Moiteaux

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2019

First Posted

June 24, 2019

Study Start

June 15, 2020

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

August 24, 2022

Record last verified: 2022-07

Locations