Prevention of Dialysis Catheter Malfunction With Prophylactic Use of a Taurolidine Containing Urokinase

Study Overview
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Brief Summary
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The objective of our study is to investigate whether the substitution of the standard locking solution with a locking solution containing taurolidine and urokinase weekly (Taurolock ™ U 25,000 - www.taurolock.com ) reduces the rate of catheter dysfunction in hemodialysis patients with a history of TCC dysfunction requiring urokinase therapy.

Official Title
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Prevention of Tunneled Cuffed Catheter Malfunction With Prophylactic Use of a Taurolidine Locking Solution Containing Urokinase : a Multicentric Randomized Controlled Trial

Conditions
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Patency, Infection

Intervention / Treatment
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* Drug: Taurolidine Urokinase
* Drug: Taurolidine Heparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult, prevalent hemodialysis patients Informed and consented Hemodialysis 3x/week via a tunneled cuffed catheter Urokinase administration at least two times during the previous 6 months (with more than a week between 2 administrations) Adequate catheter function during the week before inclusion (defined by blood flow more than 250ml/min on each dialysis session and blood flow within 15% of the maximal blood flow after the last Urokinase administration) Exclusion Criteria: Presence of heparin-induced thrombocytopenia Major hemorrhage or intracranial bleeding in the previous 3 months Pericarditis Intolerance to Taurolidine, citrate or to Urokinase Active catheter-related infection Catheter in the femoral vein

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Taurolidine Urokinase<br>Taurolock Urokinase is used weekly in this arm substituting the classic Taurolock HEP500 | Drug: Taurolidine Urokinase<br> <br> * Other names: Taurolock Urokinase 25,000;Drug: Taurolidine Heparin<br> <br> * Other names: Taurolock HEP 500;|
| Active Comparator: Taurolidine Heparin<br>Taurolock HEP 500 is used as locking solution after each dialysis session | Drug: Taurolidine Heparin<br> <br> * Other names: Taurolock HEP 500;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Requirement of Urokinase | Requirement of Urokinase for thrombotic malfunction of dialyse catheter | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Removal of dialysis catheter | Removal of dialysis catheter for thrombosis and for bacteremia | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Thrombosis, Hemodialysis, Vascular access device