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

Phase 3

Completed

• Conditions: Patency; Infection
• Interventions: Drug: Taurolidine Heparin; Drug: Taurolidine Urokinase

• Registration Number: NCT02036255
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-11
• Study First Submitted QC: 2014-01-13
• Study First Posted: 2014-01-14
• Study Start: 2015-05
• Primary Completion: 2017-07
• Status Verified: 2018-05
• Study Completion: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Taurolidine Heparin	Taurolidine Heparin	Taurolock HEP 500 is used as locking solution after each dialysis session
Taurolidine Urokinase	Taurolidine Urokinase	Taurolock Urokinase is used weekly in this arm substituting the classic Taurolock HEP500
Taurolidine Urokinase	Taurolidine Heparin	Taurolock Urokinase is used weekly in this arm substituting the classic Taurolock HEP500

Primary Outcome Measures

Name	Time	Method
Requirement of Urokinase	6 months	Requirement of Urokinase for thrombotic malfunction of dialyse catheter

Secondary Outcome Measures

Name	Time	Method
Removal of dialysis catheter	6 months	Removal of dialysis catheter for thrombosis and for bacteremia

Trial Locations

Locations (8)

UZ Antwerpen; 🇧🇪 Antwerpen, Belgium

Bracops Hospital; 🇧🇪 Anderlecht, Brussels, Belgium

CHU Charleroi; 🇧🇪 Charleroi, Hainaut, Belgium

Brugman Hospital; 🇧🇪 Jette, Brussels, Belgium

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Brussels, Belgium

CHWAPI; 🇧🇪 Tournai, Hainaut, Belgium

Ixelles Hospital; 🇧🇪 Brussels, Belgium

Ghent Hospital; 🇧🇪 Ghent, Belgium