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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00024297

Enrollment

Unknown

Registered

2003-01-27

Start date

1999-10-31

Completion date

2009-02-28

Last updated

2013-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thromboembolism

Keywords

thromboembolism

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.

Interventions

DRUGwarfarin

Study design

Primary purpose

SUPPORTIVE_CARE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion 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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026