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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00024297
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 7, 2013
Information provided by:
National Cancer Institute (NCI)

September 13, 2001
January 27, 2003
August 7, 2013
October 1999
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Complete list of historical versions of study NCT00024297 on Archive Site
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Warfarin in Preventing Blood Clots in Cancer Patients With Central Venous Catheters
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.


  • 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.

Not Applicable
Primary Purpose: Supportive Care
Drug: warfarin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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February 2009
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  • 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



  • 16 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • WBC at least 2,000/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 10 g/dL
  • No congenital bleeding disorders


  • Not specified


  • Not specified


  • No contraindication to warfarin
  • No anatomic lesions that bleed (e.g., duodenal ulcers)
  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy

  • Not specified


  • See Disease Characteristics

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • No prior enrollment on this study
  • No concurrent therapy that would interfere with study drug
  • No concurrent warfarin
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
CDR0000068909 ( Registry Identifier: PDQ (Physician Data Query) )
ISRCTN50312145 ( Registry Identifier: ISRCTN (International Standard Randomised Controlled Trial Number Register) )
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Cancer Research Campaign Clinical Trials Centre
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Study Chair: Annie Young University Hospital Birmingham
National Cancer Institute (NCI)
December 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP