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

This study has been terminated.
(Poor patient accrual)
Sponsor:
Collaborator:
Stollery Children's Hospital
Information provided by (Responsible Party):
Martin Campbell, Alberta Children's Hospital
ClinicalTrials.gov Identifier:
NCT01343680
First received: April 27, 2011
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Childhood Cancer
Aplastic Anemia
Metabolic Disorders
Drug: Heparin
Drug: Normal saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Controlled Crossover Trial of Two Different Central Venous Catheter Flushing Schemes in Pediatric Hematology and Oncology Patients in Alberta, Canada

Resource links provided by NLM:


Further study details as provided by Alberta Children's Hospital:

Primary Outcome Measures:
  • Occlusion rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complication rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: April 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 10U/l heparin Drug: Heparin
5ml 10 units/ml IV heparin 3 times per week
Experimental: normal saline Drug: Normal saline
10ml normal saline IV weekly

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.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01343680

Locations
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B6A8
Stollery Children's Hospital
Edmonton, Alberta, Canada
Sponsors and Collaborators
Alberta Children's Hospital
Stollery Children's Hospital
Investigators
Principal Investigator: Martin A Campbell, MBBS FRACP Alberta Children's Hospital
  More Information

No publications provided

Responsible Party: Martin Campbell, Paediatric Oncologist, Alberta Children's Hospital
ClinicalTrials.gov Identifier: NCT01343680     History of Changes
Other Study ID Numbers: ACH23736
Study First Received: April 27, 2011
Last Updated: May 29, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Anemia
Anemia, Aplastic
Flushing
Metabolic Diseases
Hematologic Diseases
Bone Marrow Diseases
Signs and Symptoms
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 26, 2014