A multicentre Prospective Randomised Controlled Trial of Thrombosis Prophylaxis with Warfarin in Cancer Patients with Central Venous Catheters (CVCs)
- Conditions
- Cancer
- Registration Number
- ISRCTN50312145
- Lead Sponsor
- Cancer Research UK (UK)
- Brief Summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19217991
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1400
1. Histologically or clinically confirmed diagnosis of cancer
2. Patients who are due to have a CVC inserted for administration of chemotherapy
3. Aged at least 16
4. Adequate haematological, hepatic and renal function
5. Able to provide written informed consent
1. Patients with contraindication to warfarin (including congenital bleeding disorders, anatomic lesions that bleed e.g. duodenal ulcers and profound concomitant therapy interaction)
2. Patients currently on warfarin
3. Patients who have previously been entered into WARP
4. Use of CVC for additional purposes with the exception of antibiotic therapy and blood products
5. Pregnant or lactating women
6. Fertile persons, not taking adequate contraceptive measures
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of catheter related thrombotic events
- Secondary Outcome Measures
Name Time Method 1. The number of other thrombotic events<br>2. The duration of catheter patency<br>3. The frequency and severity of trial-related adverse events<br>4. Costs:<br>a. Trial-related outpatient, inpatient and GP attendances<br>b. Diagnostic procedures for confirmation of thrombosis and cost incurred by patients and patient preference for alternative management options (dependent upon primary outcome)<br>5. Patient survival