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


Phase 3
N/A
17 Years
Not Enrolling
Both
Childhood Cancer, Aplastic Anemia, Metabolic Disorders

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Occlusion rate

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Martin A Campbell, MBBS FRACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alberta Children's Hospital

Authority:

Canada: Ethics Review Committee

Study ID:

ACH23736

NCT ID:

NCT01343680

Start Date:

April 2011

Completion Date:

May 2012

Related Keywords:

  • Childhood Cancer
  • Aplastic Anemia
  • Metabolic Disorders
  • Anemia
  • Anemia, Aplastic
  • Flushing
  • Metabolic Diseases

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