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NCT03766828 Clinical Trial

Dialysis Catheter Placement in Patients With Thoracic Central Venous Occlusion

Central Venous Catheter Thrombosis Clinical Trial

Official title:
Dialysis Catheter Placement in Patients With Thoracic Central Venous Occlusion

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03766828
Other study ID # Vienna-DialysisAccess
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2016
Est. completion date June 30, 2018

Study information
Verified date May 2019
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A unique inside-out-access technique with a new CE certified device (Surfacer (R) Bluegrass Vascular, San Antonio, Tx, USA) enables repetitive and confident right-sided placement of central venous catheters in hemodialysis patients with thoracic central venous occlusion.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date June 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients with thoracic central venous occlusion

Exclusion Criteria:

- pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• inside-out-access technique with inside-out access device (Surfacer (R))
inside-out-access technique with (Surfacer (R)) with a new CE certified device (Surfacer (R), Bluegrass Vascular)
• access technique including Sharp recanalization
access technique with Sharp recanalization via interventional radiology

Locations
Country Name City State
Austria Department of Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Achievement of dialysis access 1 day
Secondary procedure related complications infections, bleeding, hematoma or pericardial effusions and intervention related parameters 3 months
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