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Evaluation of Accuvein in Cirrhotics Patients (CIRRVVUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03996135
Recruitment Status : Not yet recruiting
First Posted : June 24, 2019
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

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®.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Device: Cannulation with AccuVein AV400 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Study of the Effectiveness of a Venous Illumination System for Peripheral Venous Pathways in Cirrhotic Patients
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental : Cannulation with AccuVein AV400
Cirrhotic patients benefit from the support of a venous illumination device for each peripheral venous cannulation
Device: Cannulation with AccuVein AV400
Cannulation using AccuVein AV400 device
Other Name: AccuVein AV400

No Intervention: Control
Cirrhotic patients benefit from the standard technique of peripheral veinous catheter placement.



Primary Outcome Measures :
  1. First Attempt Success Rate of Cannulation [ Time Frame: baseline ]
    Firt attempt success of positional for each peripheral venous catheter and expressed as a percentage in cirrhotic patients during hospitalization.


Secondary Outcome Measures :
  1. change of the score A-DIVA [ Time Frame: baseline and end of hospitalization (up to a month) ]
    Scores A-DIVA between beginning and end of hospitalization between the two groups

  2. Cost [ Time Frame: baseline ]
    Cost of consumables used in euro between the two groups

  3. Life expectancy of the catheter [ Time Frame: baseline ]
    Life expectancy of the catheter between the two groups

  4. Utilisation of a central venous catheter [ Time Frame: baseline ]
    Use of a central venous catheter (y/n)

  5. Pain's score [ Time Frame: baseline ]
    visual analogic scale

  6. Numbers of attempts [ Time Frame: baseline ]
    Number of attempts between two groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996135


Contacts
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Contact: Philippe Moiteaux 0231064542 moiteaux-p@chu-caen.fr
Contact: Nelly Orliac 0231063082 orliac-n@chu-caen.fr

Sponsors and Collaborators
University Hospital, Caen
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03996135    
Other Study ID Numbers: 19-043
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Digestive System Diseases