Prevention of Dialysis Catheter Malfunction With Prophylactic Use of a Taurolidine Containing Urokinase
NCT ID: NCT02036255
Last Updated: 2018-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
68 participants
INTERVENTIONAL
2015-05-31
2018-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Taurolidine Urokinase
Taurolock Urokinase is used weekly in this arm substituting the classic Taurolock HEP500
Taurolidine Urokinase
Taurolidine Heparin
Taurolidine Heparin
Taurolock HEP 500 is used as locking solution after each dialysis session
Taurolidine Heparin
Interventions
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Taurolidine Urokinase
Taurolidine Heparin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
99 Years
ALL
No
Sponsors
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Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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Bonkain Florence
Bonkain Florence, MD, UZ Brussel
Principal Investigators
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Florence FB Bonkain, MD
Role: PRINCIPAL_INVESTIGATOR
Universitair Ziekenhuis Brussel
Locations
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Bracops Hospital
Anderlecht, Brussels Capital, Belgium
Ixelles Hospital
Ixelles-Elsene, Brussels Capital, Belgium
Brugman Hospital
Jette, Brussels Capital, Belgium
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, Belgium
CHU Charleroi
Charleroi, Hainaut, Belgium
CHWAPI
Tournai, Hainaut, Belgium
UZ Antwerpen
Antwerp, , Belgium
Ixelles Hospital
Brussels, , Belgium
Ghent Hospital
Ghent, , Belgium
Countries
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References
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Hemmelgarn BR, Moist LM, Lok CE, Tonelli M, Manns BJ, Holden RM, LeBlanc M, Faris P, Barre P, Zhang J, Scott-Douglas N; Prevention of Dialysis Catheter Lumen Occlusion with rt-PA versus Heparin Study Group. Prevention of dialysis catheter malfunction with recombinant tissue plasminogen activator. N Engl J Med. 2011 Jan 27;364(4):303-12. doi: 10.1056/NEJMoa1011376.
Trerotola SO, Johnson MS, Harris VJ, Shah H, Ambrosius WT, McKusky MA, Kraus MA. Outcome of tunneled hemodialysis catheters placed via the right internal jugular vein by interventional radiologists. Radiology. 1997 May;203(2):489-95. doi: 10.1148/radiology.203.2.9114110.
Di Iorio BR, Bellizzi V, Cillo N, Cirillo M, Avella F, Andreucci VE, De Santo NG. Vascular access for hemodialysis: the impact on morbidity and mortality. J Nephrol. 2004 Jan-Feb;17(1):19-25.
Bonkain F, Stolear JC, Catalano C, Vandervelde D, Treille S, Couttenye MM, Dhondt A, Libertalis M, Allamani M, Madhoun P, Van Craenenbroeck AH, Vanommeslaeghe F, Van Hulle F, Durieux P, Van Limberghen I, Tielemans C, Wissing KM. Prevention of tunneled cuffed catheter dysfunction with prophylactic use of a taurolidine urokinase lock: A randomized double-blind trial. PLoS One. 2021 May 20;16(5):e0251793. doi: 10.1371/journal.pone.0251793. eCollection 2021.
Bonkain F, Van Hulle F, Janssens P, Catalano C, Allamani M, Stolear JC, Vandervelde D, Libertalis M, Treille S, Couttenye MM, Dhondt A, Van Biesen W, Fils JF, Tielemans C, Wissing KM. Urokinase-containing locking solution in the prevention of dialysis catheter dysfunction: a double blind randomized controlled trial. J Vasc Access. 2017 Sep 11;18(5):436-442. doi: 10.5301/jva.5000737. Epub 2017 Jun 14.
Other Identifiers
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TL-001
Identifier Type: -
Identifier Source: org_study_id
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