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Completed

NCT Number: NCT02036255

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

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.

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Key information

Conditions

Patency Cardiovascular Diseases Embolism and Thrombosis Infection Infections Thrombosis Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bracops Hospital, Anderlecht, Brussels Capital, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Taurolidine Urokinase

Drug

Other names: Taurolock Urokinase 25,000

Taurolidine Heparin

Drug

Other names: Taurolock HEP 500

Primary outcomes

  1. Requirement of Urokinase

    Time frame: 6 months

    Requirement of Urokinase for thrombotic malfunction of dialyse catheter

Secondary outcomes

  1. Removal of dialysis catheter

    Time frame: 6 months

    Removal of dialysis catheter for thrombosis and for bacteremia

Other outcomes

  1. Comparison of the monthly cost of both procedures

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jan 14, 2014
Registry last updated
May 3, 2018

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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