Efficacy of Urokinase Containing Locking Solutions for Thrombotic Dysfunction of Tunneled Hemodialysis Catheters

NCT ID: NCT02770560

Last Updated: 2016-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

148 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-11-30

Brief Summary

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Thrombotic dysfunction is a common complication of tunneled cuffed catheters (TCC) leading to inadequate dialysis dose, need to catheter replacement with as consequence progressive exclusion of vascular sites. Thrombolytic agent can be used as therapeutic locking solution to dissolve the clotting formed in of around the catheter lumen. There are few studies on the optimal approach of TCC-related thrombosis with thrombolytic containing locking solution (dose, number of administrations, timing of administration - intra or interdialytic use). The primary objective of this retrospective study was to compare the efficacy of inter versus intradialytic Urokinase containing locking solution on restoration of the TCC blood flow. The investigators also assess the question of multiple administrations of Urokinase are more efficient than one single administration

Detailed Description

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Conditions

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Kidney Failure, Chronic Vascular Access Devices

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Chronic hemodialysis patients with a tunneled cuffed catheter

In case of thrombotic dysfunction of the dialysis catheter : administration of Urokinase (100 000 units in total) as locking solution in the dead space of the catheter lumen, interdialytic (between two dialysis sessions) or intradialytic (during the dialysis in case of complete obstruction of the dialysis catheter)

Urokinase locking solution

Intervention Type DEVICE

On basis of the prescription : one single administration of thrombolytic locking solution versus multiple administrations (during 3 consecutive dialysis sessions)

Interventions

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Urokinase locking solution

On basis of the prescription : one single administration of thrombolytic locking solution versus multiple administrations (during 3 consecutive dialysis sessions)

Intervention Type DEVICE

Other Intervention Names

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Actosolv

Eligibility Criteria

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Inclusion Criteria

* Hemodialysis patients over 18 years old, receiving hemodialysis between 1st May 2010 and 31st October 2014 via a tunneled cuffed catheter at the Hemodialysis Unit of Universitair Ziekenhuis Brussel Hospital.

Exclusion Criteria

* Patients younger than 18 years old
* Patients with a temporary dialysis catheter
* Patients who never received a tunneled hemodialysis catheter in this period
* Patients who didn't have a medical file at the Universitair Ziekenhuis Brussel Hospital
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florence Bonkain, M.D.

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

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Universitair Ziekenhuis Brussel

Jette, Brussels Capital, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id

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