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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Childhood Cancer Aplastic Anemia Metabolic Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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10U/l heparin

Group Type ACTIVE_COMPARATOR

Heparin

Intervention Type DRUG

5ml 10 units/ml IV heparin 3 times per week

normal saline

Group Type EXPERIMENTAL

Normal saline

Intervention Type DRUG

10ml normal saline IV weekly

Interventions

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Heparin

5ml 10 units/ml IV heparin 3 times per week

Intervention Type DRUG

Normal saline

10ml normal saline IV weekly

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No