Trial of Two Central Venous Catheter (CVC) Flushing Schemes in Pediatric Hematology and Oncology Patients
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Childhood Cancer Aplastic Anemia Metabolic Disorders |
Drug: Heparin Drug: Normal saline |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: 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 |
- Occlusion rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Complication rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 2 |
| Study Start Date: | April 2011 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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.
Eligibility| Ages Eligible for Study: | up to 17 Years |
| Genders Eligible for Study: | Both |
| 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| Canada, Alberta | |
| Alberta Children's Hospital | |
| Calgary, Alberta, Canada, T3B6A8 | |
| Stollery Children's Hospital | |
| Edmonton, Alberta, Canada | |
| Principal Investigator: | Martin A Campbell, MBBS FRACP | Alberta Children's Hospital |
More Information
No publications provided
| Responsible Party: | Martin Campbell, Paediatric Oncologist, Alberta Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT01343680 History of Changes |
| Other Study ID Numbers: | ACH23736 |
| Study First Received: | April 27, 2011 |
| Last Updated: | May 29, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Additional relevant MeSH terms:
|
Anemia Anemia, Aplastic Flushing Metabolic Diseases Hematologic Diseases Bone Marrow Diseases Signs and Symptoms Calcium heparin Heparin |
Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 21, 2013