Condition category
Cancer
Date applied
17/02/2004
Date assigned
07/04/2004
Last edited
02/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Daniel Rea

ORCID ID

Contact details

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

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 measures

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

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

http://www.cancerresearchuk.org/

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

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19217991

Publication citations

  1. 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.

Additional files

Editorial Notes