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CompletedNCT02770560Updated May 12, 2016

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

An observational study in Kidney Failure, Chronic and Vascular Access Devices, sponsored by Universitair Ziekenhuis Brussel. Completed at 1 site in Belgium. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2016-05-12.

Sponsored by Universitair Ziekenhuis Brussel · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
148
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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

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Conditions studied

  • Kidney Failure, Chronic
  • Vascular Access Devices
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In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 148 is close to the median of 149 across 394 observational studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Universitair Ziekenhuis Brussel is the lead sponsor of 362 studies on the registry; 103 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Incident and prevalent patients on hemodialysis, more than 18y old, receiving dialysis via a tunneled cuffed catheter between 1st May 2010 and 31st October 2014.

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
148 participants (actual)
Patient registry
No

Groups and cohorts

  • 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)

    Device: Urokinase locking solution

Interventions

  • DeviceUrokinase locking solution

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

    Also known as: Actosolv

06

What researchers measure

Primary outcomes

  1. Change in catheter blood flow (expressed in ml/min) after Urokinase-containing locking solution

    Comparison of catheter blood flow measurement before and after Urokinase locking solution administration according to the type of Urokinase prescription (inter- versus intra-dialytic use, one- single versus multiple administrations)

    Time frame: up to 54 months

  2. Change of pump pressures (expressed in mmHg) after Urokinase-containing locking solution

    Comparison of pump pressures measurement before and after Urokinase locking solution administration according to the type of prescription of Urokinase containing locking solution (inter versus intra-dialytic, one single use versus multiple administrations)

    Time frame: up to 54 months

07

Study locations

1 site
  • Universitair Ziekenhuis Brussel
    Jette, Brussels 1090, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02770560
Lead sponsor
Universitair Ziekenhuis Brussel
Responsible party
Sponsor
First posted
May 12, 2016
Start date
May 2010
Primary completion
Oct 2014
Completion
Nov 2014
Last update
May 12, 2016

Study contacts

Florence Bonkain, M.D.
principal investigator · Universitair Ziekenhuis Brussel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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