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

Alberta Children's Hospital

Status and phase: Terminated; Phase 3

Conditions: Metabolic Disorders; Childhood Cancer; Aplastic Anemia

Treatments: Drug: Normal saline; Drug: Heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT01343680

ACH23736

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

10U/l heparin

Active Comparator group

Treatment:

Drug: Heparin

normal saline

Experimental group

Treatment:

Drug: Normal saline