Dialysis Catheter Placement in Patients With Thoracic Central Venous Occlusion

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT03766828

Collaborator

(none)

Enrollment

Location

21.9

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Central Venous Catheter Thrombosis	Procedure: inside-out-access technique with inside-out access device (Surfacer (R)) Procedure: access technique including Sharp recanalization

Study Design

Study Type:

Observational

Actual Enrollment :

36 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Dialysis Catheter Placement in Patients With Thoracic Central Venous Occlusion

Actual Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Jun 30, 2018

Actual Study Completion Date :

Jun 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
inside-out-access technique with inside-out access device	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	Procedure: access technique including Sharp recanalization access technique with Sharp recanalization via interventional radiology

Arm

Intervention/Treatment

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

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

Procedure: access technique including Sharp recanalization

access technique with Sharp recanalization via interventional radiology

Outcome Measures

Primary Outcome Measures

Achievement of dialysis access [1 day]

Secondary Outcome Measures

procedure related complications [3 months]
infections, bleeding, hematoma or pericardial effusions and intervention related parameters

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with thoracic central venous occlusion

Exclusion Criteria:

pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna	Vienna		Austria	1180

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator: Gürkan Sengölge, Department of Medicine III, Division of Nephrology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Guerkan SENGOELGE, Assoc. Prof. Priv.-Doz. Dr., Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT03766828

Other Study ID Numbers:

Vienna-DialysisAccess

First Posted:

Dec 6, 2018

Last Update Posted:

May 29, 2019

Last Verified:

May 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Guerkan SENGOELGE, Assoc. Prof. Priv.-Doz. Dr., Medical University of Vienna

thoracic central venous occlusion

Dialysis access

Additional relevant MeSH terms:

Thrombosis

Upper Extremity Deep Vein Thrombosis

Study Results

No Results Posted as of May 29, 2019