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

Aplastic Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01343680
• Other study ID #: ACH23736
• Status: Terminated
• Phase: Phase 3
• First received: April 27, 2011
• Last updated: May 29, 2012
• Start date: April 2011
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Alberta Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Heparin
5ml 10 units/ml IV heparin 3 times per week
• Normal saline
10ml normal saline IV weekly

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	Stollery Children's Hospital	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
Alberta Children's Hospital	Stollery Children's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occlusion rate		6 months	No
Secondary	Complication rate		6 months	Yes