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

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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Key information

Conditions

Kidney Failure, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Access Devices

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urokinase locking solution

Device

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

Other names: Actosolv

Primary outcomes

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

Time frame: up to 54 months

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

Time frame: up to 54 months

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)

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

Efficacy of Urokinase Containing Locking Solutions for Thrombotic Dysfunction of Tunneled Cuffed Catheters : a Single-center Retrospective Study

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2014
First posted: May 12, 2016
Registry last updated: May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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