NCT01948245

A Double Blinded, Randomized, Controlled Investigation of Taurolidine-citrate/Heparin Catheter Lock Solution Versus Heparin in Patients on Home Parenteral Nutrition With Previously Proven High Risk of Catheter Related Blood Stream Infections.

Status unknown Phase 4 Last updated 5 April 2016

What this trial tests

Phase 4 trial testing TaurolockTMHep100 in Catheter-related Bloodstream Infection (CRBSI) Nos in 42 participants. Status unknown.

Timeline

1 October 2013

Primary endpoint
1 August 2016

1 December 2016

Quick facts

Lead sponsor	Palle Bekker Jeppesen
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	42
Start date	1 October 2013
Primary completion	1 August 2016
Estimated completion	1 December 2016
Sites	1 location across Denmark

Drugs / interventions tested

• TaurolockTMHep100
• Heparin 100 IE/ml

Conditions studied

• Catheter-related Bloodstream Infection (CRBSI) Nos — all drugs for Catheter-related Bloodstream Infection (CRBSI) Nos →

Sponsor

Palle Bekker Jeppesen

Who can join

Adults 18 to 80, any sex, with Catheter-related Bloodstream Infection (CRBSI) Nos. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Mean number of catheter related blood stream infections(CRBSI)/ 1000 catheter days in each group
  Time frame: 24 months

Sponsor's own description

The purpose of the investigation is to compare two catheter lock solutions (TaurolockTMHep100 and Heparin 100 IE/ml), on the occurence of catheter related blood stream infection, in patients with intestinal failure and a central venous access device for home parenteral nutrition.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Taurolidine-citrate-heparin lock reduces catheter-related bloodstream infections in intestinal failure patients dependent on home parenteral support: a randomized, placebo-controlled trial.
   Tribler S, Brandt CF, Petersen AH, Petersen JH, et al · · 2017 · cited 55× · PMID 28793993 · DOI 10.3945/ajcn.117.158964
2. Heparin versus 0.9% sodium chloride locking for prevention of occlusion in central venous catheters in adults.
   López-Briz E, Ruiz Garcia V, Cabello JB, Bort-Martí S, et al · · 2022 · cited 15× · PMID 35849083 · DOI 10.1002/14651858.cd008462.pub4
3. UEG Week 2017 Oral Presentations
   · 2017