Warfarin in Preventing Blood Clots in Cancer Patients With Central Venous Catheters
NCT ID: NCT00024297
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
INTERVENTIONAL
1999-10-31
2009-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: Randomized clinical trial to study the effectiveness of warfarin in preventing blood clots in cancer patients who have central venous catheters.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Determine the utility of warfarin in reducing thrombosis rates in cancer patients with central venous catheters.
* Compare the thrombosis rates in patients treated with different warfarin dosing schedules.
* Compare the adverse events and survival of patients receiving or not receiving this drug.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to sclerosant potential of cytotoxic regimen (low vs high), site of placement of catheter (peripheral vs central), and duration of drug administration (brief infusion (under 24 hours) vs prolonged infusion (24 hours and over)). Patients are randomized to 1 of 3 arms.
* Arm I: Patients receive no warfarin.
* Arm II: Patients receive oral warfarin daily beginning 3 days before placement of central venous catheter (CVC) and continuing until CVC is removed or thrombosis occurs.
* Arm III: Patients receive oral warfarin as in arm II, with dose adjustment after CVC placement to achieve and maintain INR level.
Patients are followed at 12 months.
PROJECTED ACCRUAL: A total of 1,400 patients (400 in arm I, 700 in arm II, and 300 in arm III) will be accrued for this study within 2 years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
SUPPORTIVE_CARE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
warfarin
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histologically or cytologically confirmed cancer
* Planned placement of central venous catheter (CVC) for administration of chemotherapy
* No use of CVC for additional purposes except for antibiotic therapy or blood products
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 2,000/mm3
* Platelet count at least 100,000/mm3
* Hemoglobin at least 10 g/dL
* No congenital bleeding disorders
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* No contraindication to warfarin
* No anatomic lesions that bleed (e.g., duodenal ulcers)
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No prior enrollment on this study
* No concurrent therapy that would interfere with study drug
* No concurrent warfarin
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cancer Research Campaign Clinical Trials Centre
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Annie Young
Role: STUDY_CHAIR
University Hospital Birmingham
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Queen Elizabeth Hospital at University of Birmingham
Birmingham, England, United Kingdom
City Hospital - Birmingham
Birmingham, England, United Kingdom
Birmingham Heartlands and Solihull NHS Trust -Teaching
Birmingham, England, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom
Cumberland Infirmary
Carlisle, England, United Kingdom
Cheltenham General Hospital
Cheltenham, England, United Kingdom
Essex County Hospital
Colchester, England, United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom
Diana Princess of Wales Hospital
Grimsby, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, United Kingdom
Princess Royal Hospital
Hull, England, United Kingdom
Ipswich Hospital NHS Trust
Ipswich, England, United Kingdom
Royal Lancaster Infirmary
Lancaster, England, United Kingdom
Cookridge Hospital at Leeds Teaching Hospital NHS Trust
Leeds, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Guy's and St. Thomas' Hospitals NHS Foundation Trust
London, England, United Kingdom
St. George's Hospital
London, England, United Kingdom
Charing Cross Hospital
London, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom
South Tees Hospitals NHS Trust
Middlesbrough, Cleveland, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Mount Vernon Hospital
Northwood, England, United Kingdom
Royal Preston Hospital
Preston, England, United Kingdom
Oldchurch Hospital
Romford, England, United Kingdom
Royal South Hants Hospital
Southampton, England, United Kingdom
Sandwell General Hospital
West Bromwich, England, United Kingdom
Good Hope Hospital Trust
West Midlands, England, United Kingdom
Airedale General Hospital
West Yorkshire, England, United Kingdom
Royal Hampshire County Hospital
Winchester, England, United Kingdom
New Cross Hospital
Wolverhampton, England, United Kingdom
Worcester Royal Hospital
Worcester, England, United Kingdom
Ninewells Hospital and Medical School
Dundee, Scotland, United Kingdom
Royal Infirmary - Castle
Glasgow, Scotland, United Kingdom
Velindre Cancer Center at Velinde Hospital
Cardiff, Wales, United Kingdom
Singleton Hospital
Swansea, Wales, United Kingdom
Plymouth Hospitals NHS Trust
Plymouth, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CDR0000068909
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20049
Identifier Type: -
Identifier Source: secondary_id
ISRCTN50312145
Identifier Type: REGISTRY
Identifier Source: secondary_id
CRC-WARP
Identifier Type: -
Identifier Source: org_study_id