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 (NCT)	NCT00024297
Protocol serial number	G84/5337
Sponsor	Cancer Research UK (UK)
Funders	Cancer Research UK (CRUK) (UK) (ref: C2273/A3823), Medical Research Council (MRC) (UK)

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

Cancer Research UK
Institute for Cancer Studies
Clinical Trials Unit
University of Birmingham
Birmingham
B15 2TT
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	The number of catheter related thrombotic events
Key secondary outcome measure(s)	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
Completion date	15/10/2000

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Cancer Research UK

Birmingham
B15 2TT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	14/02/2009		Yes	No
Plain English results				No	Yes

Editorial Notes

17/10/2018: Cancer Research UK lay results summary link added to Results (plain English)