ThromboembolismNCT00024297
Warfarin in Preventing Blood Clots in Cancer Patients With Central Venous Catheters
A study testing warfarin in people with Thromboembolism, run by Cancer Research Campaign Clinical Trials Centre at 38 sites in United Kingdom.
Trial summary
RATIONALE: Warfarin may be effective in preventing the formation of blood clots in patients with central venous catheters. PURPOSE: Randomized clinical trial to study the effectiveness of warfarin in preventing blood clots in cancer patients who have central venous catheters. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Thromboembolism
- What is being tested?
- warfarin
- How many people
- Not given
- Where
- 38 sitesUnited Kingdom
- Study dates
- Oct 1999to Feb 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- 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
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United Kingdom38 sites
Queen Elizabeth Hospital at University of Birmingham
Birmingham, England, B15 2TT
City Hospital - Birmingham
Birmingham, England, B18 7QH
Birmingham Heartlands and Solihull NHS Trust -Teaching
Birmingham, England, B9 5SS
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, CB2 2QQ
Velindre Cancer Center at Velinde Hospital
Cardiff, Wales, CF14 2TL
Cumberland Infirmary
Carlisle, England, CA2 7HY
Cheltenham General Hospital
Cheltenham, England, GL53 7AN
Essex County Hospital
Colchester, England, C03 3NB
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW
Royal Infirmary - Castle
Glasgow, Scotland, G4 0SF
Diana Princess of Wales Hospital
Grimsby, England, DN33 2BA
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, GU2 5XX
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, HD3 3EA
Princess Royal Hospital
Hull, England, HU8 9HE
Ipswich Hospital NHS Trust
Ipswich, England, IP4 5PD
Royal Lancaster Infirmary
Lancaster, England, LA1 4RP
Cookridge Hospital at Leeds Teaching Hospital NHS Trust
Leeds, England, LS16 6QB
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Guy's and St. Thomas' Hospitals NHS Foundation Trust
London, England, SE1 9RT
St. George's Hospital
London, England, SW17 0QT
Charing Cross Hospital
London, England, W6 8RF
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, CH63 4JY
South Tees Hospitals NHS Trust
Middlesbrough, Cleveland, England, TS4 3BW
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
Mount Vernon Hospital
Northwood, England, HA6 2RN
Plymouth Hospitals NHS Trust
Plymouth, PL8 8DH
Royal Preston Hospital
Preston, England, PR2 9HT
Oldchurch Hospital
Romford, England, RM7 OBE
Royal South Hants Hospital
Southampton, England, SO14 0YG
Singleton Hospital
Swansea, Wales, SA 2 8QA
Sandwell General Hospital
West Bromwich, England, B71 4HJ
Good Hope Hospital Trust
West Midlands, England, B75 7RR
Airedale General Hospital
West Yorkshire, England, BD20 6TD
Royal Hampshire County Hospital
Winchester, England, SO22 5DG
New Cross Hospital
Wolverhampton, England, WV10 0QP
Worcester Royal Hospital
Worcester, England, WR5 1DD
About this study
Official title: A Multicenter Prospective Randomized Controlled Trial of Thrombosis Prophylaxis With Warfarin in Cancer Patients With Central Venous Catheters
RATIONALE: Warfarin may be effective in preventing the formation of blood clots in patients with central venous catheters.
PURPOSE: Randomized clinical trial to study the effectiveness of warfarin in preventing blood clots in cancer patients who have central venous catheters.
Read the detailed description
OBJECTIVES:
- 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
- Thromboembolism
- Being tested
- warfarin
- Keywords
- thromboembolism
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warfarinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startOct 1999
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
Sponsor and investigators
- Lead sponsor
- Cancer Research Campaign Clinical Trials Centre
- Sponsor type
- University, hospital or other
- Investigators
- Annie Young, Study chair, University Hospital Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00024297
- Sponsor's protocol ID
- CRC-WARP
- Other IDs
- CDR0000068909, EU-20049, ISRCTN50312145
- Status last verified
- Dec 2002
- First submitted
- 13 Sep 2001
- Last updated
- 7 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Randomized Controlled Trial of Thrombosis Prophylaxis With Warfarin in Cancer Patients With Central Venous Catheters
- ClinicalTrials.gov ID
- NCT00024297
- Acronym / sponsor ID
- CRC-WARP
- Conditions
- Thromboembolism
- Keywords
- thromboembolism
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Cancer Research Campaign Clinical Trials CentreUniversity, hospital or other
- Study start
- Oct 1999
- Study completion
- Feb 2009 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Warfarin may be effective in preventing the formation of blood clots in patients with central venous catheters.
PURPOSE: Randomized clinical trial to study the effectiveness of warfarin in preventing blood clots in cancer patients who have central venous catheters.
Detailed description
OBJECTIVES:
- 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.
Study design
- Primary purpose
- Supportive care
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| warfarin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annie Young study chair
University Hospital Birmingham
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing warfarin in people with Thromboembolism, run by Cancer Research Campaign Clinical Trials Centre at 38 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.