Concentrated Citrate Locking to Reduce the Incidence of CVC-related Complications in Hematological Patients

March 26, 2013 updated by: Maastricht University Medical Center

Concentrated Citrate Locking to Reduce the Incidence of Central Venous Catheter-related Infections and Thrombosis: a Randomized Phase III Study in a Hematological Patient Population

Patients with a hematological malignancy who are undergoing intensive chemotherapy need a central venous catheter (CVC)during their treatment. CVCs are locked with heparin when they are not used.

The purpose of this study is to determine whether concentrated citrate locking, compared to heparin, reduces the incidence of central venous catheter-related thrombosis and infections in patients with hematological malignancies undergoing intensive chemotherapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Central venous catheter (CVC)-related thrombosis and infections are frequently occurring complications and may cause significant morbidity in patients with hematological malignancies. Interventions to decrease fibrin deposition have the potential to reduce CVC-related thrombosis and infections.

At present heparin is most often used as locking solution for central venous catheters in hematological patients despite a lack of evidence regarding the efficacy and safety. Trisodium citrate (TSC) had been shown to be an effective antimicrobial catheter locking in hemodialysis patients.

Study Type

Interventional

Enrollment (Actual)

212

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Heerlen, Netherlands, 6419PC
        • Atrium Medical Center Parkstad Heerlen
      • Maastricht, Netherlands, 6202AZ
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with hematological malignancies who were going to receive a CVC for intensive chemotherapy including patients for stem cell transplantation
  • written informed consent
  • 18 years or older

Exclusion Criteria:

  • the presence of a central venous catheter at admission
  • history of central venous catheter related thrombosis or infection
  • indication for anticoagulant treatment or prophylaxis
  • patients with totally implanted catheters
  • catheters impregnated with antimicrobial agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A: heparin (Heparin LEO)
After each use, the central venous catheter lumen will be flushed with 10 ml 0.9% NaCl and then locked with heparin 5000 IU/ml(standard treatment)using a volume exactly equivalent to the internal volume noted on each catheter.
Procedure: heparin
when not in use CVCs are locked with heparin
Experimental: B: concentrated citrate (Citralock)
locking the central venous catheter with concentrated citrate after each use
Procedure: concentrated citrate
when not in use the CVC is locked with concentrated citrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
central venous catheter-related thrombosis
Time Frame: weekly from date of randomization until removal of the central venous catheter, up to one year
Patients will be followed from insertion of the central venous catheter till removal of the central venous catheter, an expected average of 30 days. The central venous catheter is seen daily and checked for thrombosis and infections when the patient is admitted on the ward. Discharged patients are seen at least weekly on the outpatients clinic and their central venous catheter is checked for thrombosis and infections. A standard ultrasound is made 30 days after insertion and within 24 hours after removal of the central venous catheter.
weekly from date of randomization until removal of the central venous catheter, up to one year
central venous catheter-related infections
Time Frame: weekly from date of randomization untill the removal of the central venous catheter; up to one year
weekly from date of randomization untill the removal of the central venous catheter; up to one year

Secondary Outcome Measures

Outcome Measure
Time Frame
premature removal of the catheter
Time Frame: weekly from date of randomization untill removal of the central venous catheter; up to one year
weekly from date of randomization untill removal of the central venous catheter; up to one year
failure to aspirate blood
Time Frame: weekly from date of randomization untill the removal of the central venous catheter; up to one year
weekly from date of randomization untill the removal of the central venous catheter; up to one year
hypocalcemic symptoms
Time Frame: weekly from dateof randomization untill the removal of the central venous catheter; up to one year
weekly from dateof randomization untill the removal of the central venous catheter; up to one year
severe bleeding
Time Frame: weekly from date of randomization untill the removal of the central venous catheter; up to one year
weekly from date of randomization untill the removal of the central venous catheter; up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Dirinco B.V.

Investigators

  • Principal Investigator: Harry Schouten, MD, Maastricht University Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

March 12, 2013

First Submitted That Met QC Criteria

March 26, 2013

First Posted (Estimate)

March 29, 2013

Study Record Updates

Last Update Posted (Estimate)

March 29, 2013

Last Update Submitted That Met QC Criteria

March 26, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC06-2-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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