A multicentre Prospective Randomised Controlled Trial of Thrombosis Prophylaxis with Warfarin in Cancer Patients with Central Venous Catheters (CVCs)
| ISRCTN | ISRCTN50312145 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50312145 |
| ClinicalTrials.gov number | NCT00024297 |
| Secondary identifying numbers | G84/5337 |
- Submission date
- 17/02/2004
- Registration date
- 07/04/2004
- Last edited
- 17/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
http://cancerhelp.cancerresearchuk.org/trials/how-much-warfarin-prevents-catheter-clots
Contact information
Dr Daniel Rea
Scientific
Scientific
Cancer Research UK
Institute for Cancer Studies
Clinical Trials Unit
University of Birmingham
Birmingham
B15 2TT
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | A multicentre Prospective Randomised Controlled Trial of Thrombosis Prophylaxis with Warfarin in Cancer Patients with Central Venous Catheters (CVCs) |
| Study acronym | WARP |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/12/1999 |
| Completion date | 15/10/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1400 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/1999 |
| Date of final enrolment | 15/10/2000 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cancer Research UK
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
Cancer Research UK (UK)
Charity
Charity
Institute for Cancer Studies
Clinical Trials Unit
University of Birmingham
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 4143793 |
|---|---|
| a.young@bham.ac.uk | |
| Website | http://www.cancerresearchuk.org/ |
"ROR" |
https://ror.org/054225q67 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK) (ref: C2273/A3823)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | results | 14/02/2009 | Yes | No |
Editorial Notes
17/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
