Warfarin in Preventing Blood Clots in Cancer Patients With Central Venous Catheters

August 6, 2013 updated by: Cancer Research Campaign Clinical Trials Centre

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.

Study Overview

Status

Completed

Conditions

Thromboembolism

Intervention / Treatment

Drug: warfarin

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 Type

Interventional

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- - Plymouth, United Kingdom, PL8 8DH
    - Plymouth Hospitals NHS Trust
- England
  - Birmingham, England, United Kingdom, B18 7QH
    - City Hospital - Birmingham
  - Birmingham, England, United Kingdom, B15 2TT
    - Queen Elizabeth Hospital at University of Birmingham
  - Birmingham, England, United Kingdom, B9 5SS
    - Birmingham Heartlands and Solihull NHS Trust -Teaching
  - Bristol, England, United Kingdom, BS2 8ED
    - Bristol Haematology and Oncology Centre
  - Cambridge, England, United Kingdom, CB2 2QQ
    - Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
  - Carlisle, England, United Kingdom, CA2 7HY
    - Cumberland Infirmary
  - Cheltenham, England, United Kingdom, GL53 7AN
    - Cheltenham General Hospital
  - Colchester, England, United Kingdom, C03 3NB
    - Essex County Hospital
  - Exeter, England, United Kingdom, EX2 5DW
    - Royal Devon and Exeter Hospital
  - Grimsby, England, United Kingdom, DN33 2BA
    - Diana Princess of Wales Hospital
  - Guildford, England, United Kingdom, GU2 5XX
    - St. Luke's Cancer Centre at Royal Surrey County Hospital
  - Huddersfield, West Yorks, England, United Kingdom, HD3 3EA
    - Huddersfield Royal Infirmary
  - Hull, England, United Kingdom, HU8 9HE
    - Princess Royal Hospital
  - Ipswich, England, United Kingdom, IP4 5PD
    - Ipswich Hospital NHS Trust
  - Lancaster, England, United Kingdom, LA1 4RP
    - Royal Lancaster Infirmary
  - Leeds, England, United Kingdom, LS9 7TF
    - Leeds Cancer Centre at St. James's University Hospital
  - Leeds, England, United Kingdom, LS16 6QB
    - Cookridge Hospital at Leeds Teaching Hospital NHS Trust
  - London, England, United Kingdom, SW17 0QT
    - St. George's Hospital
  - London, England, United Kingdom, SE1 9RT
    - Guy's and St. Thomas' Hospitals NHS Foundation Trust
  - London, England, United Kingdom, W6 8RF
    - Charing Cross Hospital
  - Merseyside, England, United Kingdom, CH63 4JY
    - Clatterbridge Centre for Oncology NHS Trust
  - Middlesbrough, Cleveland, England, United Kingdom, TS4 3BW
    - South Tees Hospitals NHS Trust
  - Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE
    - Northern Centre for Cancer Treatment at Newcastle General Hospital
  - Northwood, England, United Kingdom, HA6 2RN
    - Mount Vernon Hospital
  - Preston, England, United Kingdom, PR2 9HT
    - Royal Preston Hospital
  - Romford, England, United Kingdom, RM7 OBE
    - Oldchurch Hospital
  - Southampton, England, United Kingdom, SO14 0YG
    - Royal South Hants Hospital
  - West Bromwich, England, United Kingdom, B71 4HJ
    - Sandwell General Hospital
  - West Midlands, England, United Kingdom, B75 7RR
    - Good Hope Hospital Trust
  - West Yorkshire, England, United Kingdom, BD20 6TD
    - Airedale General Hospital
  - Winchester, England, United Kingdom, SO22 5DG
    - Royal Hampshire County Hospital
  - Wolverhampton, England, United Kingdom, WV10 0QP
    - New Cross Hospital
  - Worcester, England, United Kingdom, WR5 1DD
    - Worcester Royal Hospital
- Scotland
  - Dundee, Scotland, United Kingdom, DD1 9SY
    - Ninewells Hospital and Medical School
  - Glasgow, Scotland, United Kingdom, G4 0SF
    - Royal Infirmary - Castle
- Wales
  - Cardiff, Wales, United Kingdom, CF14 2TL
    - Velindre Cancer Center at Velinde Hospital
  - Swansea, Wales, United Kingdom, SA 2 8QA
    - Singleton Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Supportive Care

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Research Campaign Clinical Trials Centre

Investigators

Study Chair: Annie Young, University Hospital Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1999

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

September 13, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

December 1, 2002

More Information

Terms related to this study

Keywords

thromboembolism

Additional Relevant MeSH Terms

Other Study ID Numbers

CRC-WARP
CDR0000068909 (Registry Identifier: PDQ (Physician Data Query))
EU-20049
ISRCTN50312145 (Registry Identifier: ISRCTN (International Standard Randomised Controlled Trial Number Register))

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