NCT03766828

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
Last Updated

May 29, 2019

Status Verified

May 1, 2019

Enrollment Period

1.8 years

First QC Date

December 4, 2018

Last Update Submit

May 27, 2019

Conditions

Central Venous Catheter Thrombosis

Keywords

thoracic central venous occlusionDialysis access

Outcome Measures

Primary Outcomes (1)

  • Achievement of dialysis access

    1 day

Secondary Outcomes (1)

  • procedure related complications

    3 months

Study Arms (2)

inside-out-access technique with inside-out access device

Procedure: inside-out-access technique with inside-out access device (Surfacer (R))

access technique including Sharp recanalization

Procedure: access technique including Sharp recanalization

Interventions

inside-out-access technique with inside-out access device (Surfacer (R))PROCEDURE

inside-out-access technique with (Surfacer (R)) with a new CE certified device (Surfacer (R), Bluegrass Vascular)

inside-out-access technique with inside-out access device
access technique including Sharp recanalizationPROCEDURE

access technique with Sharp recanalization via interventional radiology

access technique including Sharp recanalization

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hemodialysis patients with thoracic central venous occlusion requiring vascular access

You may qualify if:

  • Patients with thoracic central venous occlusion

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna

Vienna, 1180, Austria

Location

MeSH Terms

Conditions

Upper Extremity Deep Vein Thrombosis

Condition Hierarchy (Ancestors)

Venous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Gürkan Sengölge

    Department of Medicine III, Division of Nephrology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Priv.-Doz. Dr.

Study Record Dates

First Submitted

December 4, 2018

First Posted

December 6, 2018

Study Start

September 1, 2016

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

May 29, 2019

Record last verified: 2019-05

Locations

AU(1)