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

• Sponsor: Universitair Ziekenhuis Brussel (Other)
• Overall Status: Completed
• CT.gov ID: NCT02036255
• Collaborator: (none)
• Enrollment: 68
• Locations: 9
• Arms: 2
• Duration (Months): 36
• Patients Per Site: 7.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patency; Infection	Drug: Taurolidine Urokinase; Drug: Taurolidine Heparin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Prevention of Tunneled Cuffed Catheter Malfunction With Prophylactic Use of a Taurolidine Locking Solution Containing Urokinase : a Multicentric Randomized Controlled Trial
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: Jul 1, 2017
• Actual Study Completion Date: May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Taurolidine Urokinase Taurolock Urokinase is used weekly in this arm substituting the classic Taurolock HEP500	Drug: Taurolidine Urokinase; Other Names: Taurolock Urokinase 25,000 ; Drug: Taurolidine Heparin; Other Names: Taurolock HEP 500
Active Comparator: Taurolidine Heparin Taurolock HEP 500 is used as locking solution after each dialysis session	Drug: Taurolidine Heparin; Other Names: Taurolock HEP 500

Outcome Measures

Primary Outcome Measures

1. Requirement of Urokinase [6 months]

   Requirement of Urokinase for thrombotic malfunction of dialyse catheter

Secondary Outcome Measures

1. Removal of dialysis catheter [6 months]

   Removal of dialysis catheter for thrombosis and for bacteremia

Other Outcome Measures

1. Comparison of the monthly cost of both procedures [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bracops Hospital	Anderlecht	Brussels	Belgium	1070
2	Ixelles Hospital	Ixelles	Brussels	Belgium	1050
3	Brugman Hospital	Jette	Brussels	Belgium	1090
4	Universitair Ziekenhuis Brussel	Jette	Brussels	Belgium	1090
5	CHU Charleroi	Charleroi	Hainaut	Belgium
6	CHWAPI	Tournai	Hainaut	Belgium	7500
7	UZ Antwerpen	Antwerpen		Belgium
8	Ixelles Hospital	Brussels		Belgium	1050
9	Ghent Hospital	Ghent		Belgium

Sponsors and Collaborators

• Universitair Ziekenhuis Brussel

Investigators

• Principal Investigator: Florence FB Bonkain, MD, Universitair Ziekenhuis Brussel

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Bonkain Florence, Bonkain Florence, MD, UZ Brussel, Universitair Ziekenhuis Brussel
• ClinicalTrials.gov Identifier: NCT02036255
• Other Study ID Numbers: TL-001
• First Posted: Jan 14, 2014
• Last Update Posted: May 3, 2018
• Last Verified: May 1, 2018

• Keywords provided by Bonkain Florence, Bonkain Florence, MD, UZ Brussel, Universitair Ziekenhuis Brussel: Prevention, Thrombosis, Hemodialysis, Vascular access device
• Additional relevant MeSH terms: Taurolidine; Heparin

Study Results

No Results Posted as of May 3, 2018