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Neutrolin Versus Heparin for Locking Hemodialysis Catheters

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ClinicalTrials.gov Identifier: NCT03425448
Recruitment Status : Not yet recruiting
First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Information provided by (Responsible Party):
Dr. Mubarak Al Abdalla, King Abdullah International Medical Research Center

Brief Summary:

Hemodialysis catheter related bacterial infections represent a major cause of mortality and morbidity in the hemodialysis population. Several locking agents had been tried with variable degree of success but not without side effects.

Neutrolin catheter locking agent comprises of heparin,citrate and trauolidine that had been studied in a prospective study in Germany, and it demonstrated a very good result in terms of reducing the catheter related infections and thrombosis.

This study is a multi-center, double-blind RCT comparing the hemodialysis catheter locking solution Neutrolin with heparin in reducing the rate of catheter related bacterial infection and thrombosis.

Condition or disease Intervention/treatment
Hemodialysis Catheter Infection Catheter Thrombosis Drug: Heparin Device: Neutrolin

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Multi-center, double-blind, randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neutrolin Versus Heparin for Locking Hemodialysis Catheters: A Multi-center, Double-Blind, Randomized Controlled Trial
Anticipated Study Start Date : March 4, 2018
Estimated Primary Completion Date : December 4, 2018
Estimated Study Completion Date : September 4, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Heparin group Drug: Heparin
Heparin hemodialysis catheter lock solution
Experimental: Neotrolin Group Device: Neutrolin
Neutrolin hemodialysis catheter lock

Primary Outcome Measures :
  1. Proportion of catheter related blood stream infections (CRBSI per 1000 CVC days) [ Time Frame: 18 month ]
    Rate of hemodialysis catheter in each study arm

Secondary Outcome Measures :
  1. Proportion of hemodialysis catheters with poor flow due to thrombosis [ Time Frame: 18 month ]
    Rate of catheter dysfunction in each group

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • New hemodialysis catheter
  • Subject who will need chronic hemodialysis at least twice/week
  • Subject likely to require for at least 120 days
  • Subject or relative is likely to understand the nature of the study and sign the consent
  • Age 18 years and older

Exclusion Criteria:

  • Subject with unstable malignancy
  • Subject with liver cirrhosis with encephalopathy
  • Subject know to have allergy to heparin, citrate or traoulidine
  • Documented history of arterial thrombosis or known to have hypercoagulable state
  • Subjects with active skin infections and ulcers

Responsible Party: Dr. Mubarak Al Abdalla, Consultant Nephrologist and Assistant Professor, King Abdullah International Medical Research Center
ClinicalTrials.gov Identifier: NCT03425448     History of Changes
Other Study ID Numbers: RC17/083/R
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action