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

NCT02036255 | Completed Phase 3 DMC

• 1 other identifier: TL-001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 9

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.

Conditions

Patency; Infection

Keywords

Prevention, Thrombosis, Hemodialysis, Vascular access device

Outcome Measures

Primary Outcomes (1)

• Requirement of Urokinase

  Requirement of Urokinase for thrombotic malfunction of dialyse catheter

  6 months

Secondary Outcomes (1)

• Removal of dialysis catheter

  6 months

Other Outcomes (1)

• Comparison of the monthly cost of both procedures

  6 months

Study Arms (2)

Taurolidine Urokinase

EXPERIMENTAL

Taurolock Urokinase is used weekly in this arm substituting the classic Taurolock HEP500

Drug: Taurolidine Urokinase; Drug: Taurolidine Heparin

Taurolidine Heparin

ACTIVE COMPARATOR

Taurolock HEP 500 is used as locking solution after each dialysis session

Drug: Taurolidine Heparin

Interventions

Taurolidine Urokinase DRUG

Also known as: Taurolock Urokinase 25,000

Taurolidine Urokinase

Taurolidine Heparin DRUG

Also known as: Taurolock HEP 500

Taurolidine Heparin; Taurolidine Urokinase

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (9)

Bracops Hospital

Anderlecht, Brussels Capital, 1070, Belgium

Location

Ixelles Hospital

Ixelles-Elsene, Brussels Capital, 1050, Belgium

Location

Brugman Hospital

Jette, Brussels Capital, 1090, Belgium

Location

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

Location

CHU Charleroi

Charleroi, Hainaut, Belgium

Location

CHWAPI

Tournai, Hainaut, 7500, Belgium

Location

UZ Antwerpen

Antwerp, Belgium

Location

Ixelles Hospital

Brussels, 1050, Belgium

Location

Ghent Hospital

Ghent, Belgium

Location

Related Publications (5)

• 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.

  PMID: 21268722 BACKGROUND

• 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.

  PMID: 9114110 BACKGROUND

• 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.

  PMID: 15151255 BACKGROUND

• 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.

  PMID: 34015014 DERIVED

• 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.

  PMID: 28623638 DERIVED

MeSH Terms

Conditions

Infections; Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Florence FB Bonkain, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bonkain Florence, MD, UZ Brussel

Study Record Dates

• First Submitted: January 11, 2014
• First Posted: January 14, 2014
• Study Start: May 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: May 1, 2018
• Last Updated: May 3, 2018

Record last verified: 2018-05

Locations

BE (9)