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

• Sponsor: Alberta Children's Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01343680
• Collaborator: Stollery Children's Hospital (Other)
• Enrollment: 2
• Locations: 2
• Arms: 2
• Duration (Months): 13
• Patient Per Site: 1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Apr 1, 2011
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Occlusion rate [6 months]

Secondary Outcome Measures

1. Complication rate [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Alberta Children's Hospital	Calgary	Alberta	Canada	T3B6A8
2	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Martin Campbell, Paediatric Oncologist, Alberta Children's Hospital
• ClinicalTrials.gov Identifier: NCT01343680
• Other Study ID Numbers: ACH23736
• First Posted: Apr 28, 2011
• Last Update Posted: May 30, 2012
• Last Verified: May 1, 2012

• Additional relevant MeSH terms: Anemia, Aplastic; Metabolic Diseases; Flushing; Heparin

Study Results

No Results Posted as of May 30, 2012