ClinicalTrials.Veeva

Menu

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

U

Universitair Ziekenhuis Brussel

Status and phase

Completed
Phase 3

Conditions

Infection
Patency

Treatments

Drug: Taurolidine Urokinase
Drug: Taurolidine Heparin

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

68 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

68 participants in 2 patient groups

Taurolidine Urokinase
Experimental group
Description:
Taurolock Urokinase is used weekly in this arm substituting the classic Taurolock HEP500
Treatment:
Drug: Taurolidine Heparin
Drug: Taurolidine Urokinase
Taurolidine Heparin
Active Comparator group
Description:
Taurolock HEP 500 is used as locking solution after each dialysis session
Treatment:
Drug: Taurolidine Heparin

Trial contacts and locations

9

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems