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Urokinase-containing locking solution in the prevention of dialysis catheter dysfunction: a double blind randomized controlled trial

Abstract

Introduction

The prophylactic use of recombinant tissue plasminogen activator once weekly reduces the incidence rate of tunneled cuffed catheter (TCC) malfunction and bacteremia as compared to the exclusive use of heparin as locking solution. Restricting the use of prophylactic thrombolytic agents to patients with a history of thrombotic TCC malfunction could be more cost effective. We conduct a multicenter, double-blind, randomized controlled trial and test the hypothesis that weekly use of urokinase lock will reduce the incidence of thrombotic malfunction by 50% in prevalent hemodialysis patients with a history of thrombotic malfunction.

Methods

Patients with a history of at least two separate TCC thrombotic dysfunctions treated with urokinase lock during the 6 months preceding inclusion are recruited in eight Belgian dialysis units. Patients are randomized in two groups: the control group receiving Taurolock™-HEP500 (heparin 500 IU/mL, taurolidine, citrate 4%) after each hemodialysis session and the treatment group receiving Taurolock-U 25,000 (urokinase 25,000, taurolidine, citrate 4%) once a week and the standard Taurolock-HEP500 at the end of the two others sessions. The primary outcome is the incidence rate of TCC thrombotic dysfunction defined by the use of urokinase. The secondary outcomes are the incidence rate of TCC removal and systemic thrombolysis. For the study, both patients and healthcare staff are blinded to treatment allocation.

Conclusions

The present trial is the first to investigate the effect of Taurolock-U 25,000 catheter lock once a week as secondary prevention in hemodialysis patients with the highest risk of TCC-related thrombotic dysfunction.

Trial registration

ClinicalTrials.gov Identifier: NCT02036255

J Vasc Access 2017; 18(5): 436 - 442

Article Type: CLINICAL TRIAL PROTOCOL

DOI:10.5301/jva.5000737

Authors

Florence Bonkain, Freya Van Hulle, Peter Janssens, Concetta Catalano, Mandelina Allamani, Jean-Claude Stolear, Dominique Vandervelde, Mark Libertalis, Serge Treille, Marie M. Couttenye, Annemie Dhondt, Wim Van Biesen, Jean François Fils, Christian Tielemans, Karl M. Wissing

Article History

Disclosures

Financial support: None of the investigators has received funding from Tauro-Implant for work realized in the context of the present clinical trial. Tauro-Implant provides the study medication and the corresponding placebo free of charge to the patients participating in the trial. Tauro-Implant does not provide additional funds for the realization of the trial, has not participated in the writing of the study protocol and has no role in the collection of data, as well as analysis, interpretation and presentation of the results.
Conflict of interest: None of the authors has financial interest related to this study to disclose.

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Authors

Affiliations

  •  Nephrology Department, Universitair Ziekenhuis, Brussels - Belgium
  •  Nephrology Department, CHU Brugmann, Brussels - Belgium
  •  Nephrology Department, Centre Hospitalier de Wallonie Picarde, IMC Tournai - Belgium
  •  Nephrology Department, Hôpitaux iris Sud, site Bracops, Etterbeek - Belgium
  •  Nephrology Department, Hôpitaux iris Sud, site Ixelles, Etterbeek - Belgium
  •  Nephrology Department, CHU Charleroi - Belgium
  •  Nephrology Department, Universitair Ziekenhuis Antwerpen, Edegem - Belgium
  •  Nephrology Department, Ghent University Hospital, Ghent - Belgium
  •  Freelance Biostatistician, Ars Statistica, Nivelles - Belgium

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