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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00024297
First received: September 13, 2001
Last updated: August 6, 2013
Last verified: December 2002
  Purpose

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.


Condition Intervention
Thromboembolism
Drug: warfarin

Study Type: Interventional
Study Design: Primary Purpose: Supportive Care
Official Title: A Multicenter Prospective Randomized Controlled Trial of Thrombosis Prophylaxis With Warfarin in Cancer Patients With Central Venous Catheters

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 1999
Study Completion Date: February 2009
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00024297

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00024297     History of Changes
Other Study ID Numbers: CRC-WARP, CDR0000068909, EU-20049, ISRCTN50312145
Study First Received: September 13, 2001
Last Updated: August 6, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
thromboembolism

Additional relevant MeSH terms:
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014