Plain English Summary
http://cancerhelp.cancerresearchuk.org/trials/how-much-warfarin-prevents-catheter-clots
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00024297
Protocol/serial number
G84/5337
Study information
Scientific title
Acronym
WARP
Study hypothesis
Primary:
1. To determine the utility of warfarin in cancer patients with CVCs in reducing thrombosis rates
Secondary:
2. To determine whether different warfarin dosing strategies lead to different thrombosis rates
3. To monitor the trial-related adverse events across the three arms
4. To compare the trial-related costs between the three arms
5. To compare survival of patients in the warfarin and no warfarin arms
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Cancer
Intervention
Uncertain one indication for warfarin for prophylaxis of thrombosis:
Intervention A - No warfarin
Intervention B - Warfarin 1 mg/day (fixed dose)
Intervention C - Warfarin - individualised dose to maintain International Normalised Ratio (INR) between 1.5 and 2.0
or
Uncertain two indication for warfarin for prophylaxis of thrombosis:
Intervention A - No warfarin
Intervention B - Warfarin 1 mg/day (fixed dose)
Certain indication for warfarin for prophylaxis of thrombosis:
Intervention B - Warfarin 1 mg/day (fixed dose)
Intervention C - Warfarin - individualised dose to maintain INR between 1.5 and 2.0
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The number of catheter related thrombotic events
Secondary outcome measures
1. The number of other thrombotic events
2. The duration of catheter patency
3. The frequency and severity of trial-related adverse events
4. Costs:
a. Trial-related outpatient, inpatient and GP attendances
b. Diagnostic procedures for confirmation of thrombosis and cost incurred by patients and patient preference for alternative management options (dependent upon primary outcome)
5. Patient survival
Overall trial start date
01/12/1999
Overall trial end date
15/10/2000
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1400
Participant exclusion criteria
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
Recruitment start date
01/12/1999
Recruitment end date
15/10/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cancer Research UK
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
Cancer Research UK (UK)
Sponsor details
Institute for Cancer Studies
Clinical Trials Unit
University of Birmingham
Birmingham
B15 2TT
United Kingdom
+44 (0)121 4143793
a.young@bham.ac.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) (ref: C2273/A3823)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19217991
Publication citations
-
Results
Young AM, Billingham LJ, Begum G, Kerr DJ, Hughes AI, Rea DW, Shepherd S, Stanley A, Sweeney A, Wilde J, Wheatley K, , Warfarin thromboprophylaxis in cancer patients with central venous catheters (WARP): an open-label randomised trial., Lancet, 2009, 373, 9663, 567-574, doi: 10.1016/S0140-6736(09)60205-1.