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

Phase 3

Terminated

• Conditions: Childhood Cancer; Aplastic Anemia; Metabolic Disorders
• Interventions: Drug: Heparin; Drug: Normal saline

• Registration Number: NCT01343680
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-27
• Study First Submitted QC: 2011-04-27
• Study First Posted: 2011-04-28
• Status Verified: 2012-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2012-05-29
• Last Update Posted: 2012-05-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
10U/l heparin	Heparin	-
normal saline	Normal saline	-

Primary Outcome Measures

Name	Time	Method
Occlusion rate	6 months

Secondary Outcome Measures

Name	Time	Method
Complication rate	6 months

Trial Locations

Locations (2)

Stollery Children's Hospital; 🇨🇦 Edmonton, Alberta, Canada

Alberta Children's Hospital; 🇨🇦 Calgary, Alberta, Canada