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

Primary Purpose

Childhood Cancer, Aplastic Anemia, Metabolic Disorders

Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Heparin
Normal saline
Sponsored by
Alberta Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Cancer

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alberta Children's Hospital
  • Stollery Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

10U/l heparin

normal saline

Arm Description

Outcomes

Primary Outcome Measures

Occlusion rate

Secondary Outcome Measures

Complication rate

Full Information

First Posted
April 27, 2011
Last Updated
May 29, 2012
Sponsor
Alberta Children's Hospital
Collaborators
Stollery Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01343680
Brief Title
Trial of Two Central Venous Catheter (CVC) Flushing Schemes in Pediatric Hematology and Oncology Patients
Official Title
A Randomized Controlled Crossover Trial of Two Different Central Venous Catheter Flushing Schemes in Pediatric Hematology and Oncology Patients in Alberta, Canada
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
Poor patient accrual
Study Start Date
April 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alberta Children's Hospital
Collaborators
Stollery Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Cancer, Aplastic Anemia, Metabolic Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10U/l heparin
Arm Type
Active Comparator
Arm Title
normal saline
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Heparin
Intervention Description
5ml 10 units/ml IV heparin 3 times per week
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
10ml normal saline IV weekly
Primary Outcome Measure Information:
Title
Occlusion rate
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Complication rate
Time Frame
6 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin A Campbell, MBBS FRACP
Organizational Affiliation
Alberta Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B6A8
Country
Canada
Facility Name
Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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