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

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ClinicalTrials.gov Identifier: NCT01343680
Recruitment Status : Terminated (Poor patient accrual)
First Posted : April 28, 2011
Last Update Posted : May 30, 2012
Sponsor:
Collaborator:
Stollery Children's Hospital
Information provided by (Responsible Party):
Martin Campbell, Alberta Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Childhood Cancer Aplastic Anemia Metabolic Disorders Drug: Heparin Drug: Normal saline Phase 3

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  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : April 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Occlusion rate [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Complication rate [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Martin Campbell, Paediatric Oncologist, Alberta Children's Hospital
ClinicalTrials.gov Identifier: NCT01343680     History of Changes
Other Study ID Numbers: ACH23736
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: May 30, 2012
Last Verified: May 2012

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