Trial of Two Central Venous Catheter (CVC) Flushing Schemes in Pediatric Hematology and Oncology Patients

May 29, 2012 updated by: Martin Campbell, Alberta Children's Hospital

A Randomized Controlled Crossover Trial of Two Different Central Venous Catheter Flushing Schemes in Pediatric Hematology and Oncology Patients in Alberta, Canada

The purpose of this study is to determine whether flushing Central Venous Catheters (CVCs) with Normal saline once per week is not inferior to flushing with 10U/ml heparin 3 times per week, in preventing CVC occlusions.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Tunneled central venous catheters (CVCs) are now used routinely in pediatric hematology and oncology patients. Flushing with heparin solution is routinely recommended to prevent occlusion of long term CVCs, although the concentration of heparin used, and frequency of its use varies between centres. Once weekly Normal saline is also used successfully in some pediatric enters. There is little evidence to support one method over the other.

The investigators have designed a randomised crossover trial to directly compare once weekly Normal saline flushing with 3 times per week 10U/ml heparin flushing, to determine whether Normal saline is not inferior to heparin.

Study Type

Interventional

Enrollment (Actual)

2

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B6A8
        • Alberta Children's Hospital
      • Edmonton, Alberta, Canada
        • Stollery Children'S Hospital

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

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Diagnosis of any malignant or nonmalignant disease that requires a single lumen Broviac or double lumen Hickman-type CVC for the purpose of chemotherapy, blood product support or hematopoietic stem cell transplantation.
  • CVC is planned to remain in situ for 6 months from study entry

Exclusion Criteria:

  • Thrombophilia (e.g. Factor V Leiden mutation, antiphospholipid syndrome) or previous thrombosis requiring anticoagulation (e.g. enoxaparin, unfractionated heparin)
  • Bleeding disorder (e.g. von Willebrand's disease, hemophilia)
  • Previous CVC that was removed due to any complication

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: normal saline
Drug: Normal saline
10ml normal saline IV weekly
Active Comparator: 10U/l heparin
Drug: Heparin
5ml 10 units/ml IV heparin 3 times per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occlusion rate
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Complication rate
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Alberta Children's Hospital

Collaborators

Stollery Children's Hospital

Investigators

  • Principal Investigator: Martin A Campbell, MBBS FRACP, Alberta Children's Hospital

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

April 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

April 27, 2011

First Submitted That Met QC Criteria

April 27, 2011

First Posted (Estimate)

April 28, 2011

Study Record Updates

Last Update Posted (Estimate)

May 30, 2012

Last Update Submitted That Met QC Criteria

May 29, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACH23736

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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