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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2002 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00024297

First received: September 13, 2001

Last updated: May 9, 2009

Last verified: December 2002

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2001

Last Updated Date

May 9, 2009

Start Date ^ICMJE

October 1999

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00024297 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Multicenter Prospective Randomized Controlled Trial of Thrombosis Prophylaxis With Warfarin in Cancer Patients With Central Venous Catheters

Brief Summary

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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Primary Purpose: Supportive Care

Condition ^ICMJE

Thromboembolism

Intervention ^ICMJE

Drug: warfarin

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00024297

Other Study ID Numbers ^ICMJE

CDR0000068909, CRC-WARP, EU-20049

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Cancer Research Campaign Clinical Trials Centre

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Annie Young

University Hospital Birmingham

Information Provided By

National Cancer Institute (NCI)

Verification Date

December 2002

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

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