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

Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00024297
• Other study ID #: CRC-WARP
• Secondary ID: CDR0000068909EU-
• Status: Completed
• Phase: N/A
• First received: September 13, 2001
• Last updated: August 6, 2013
• Start date: October 1999
• Est. completion date: February 2009

Study information

• Verified date: December 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Thromboembolism

Intervention

Drug:
• warfarin

Locations

Country	Name	City	State
United Kingdom	Birmingham Heartlands and Solihull NHS Trust -Teaching	Birmingham	England
United Kingdom	City Hospital - Birmingham	Birmingham	England
United Kingdom	Queen Elizabeth Hospital at University of Birmingham	Birmingham	England
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust	Cambridge	England
United Kingdom	Velindre Cancer Center at Velinde Hospital	Cardiff	Wales
United Kingdom	Cumberland Infirmary	Carlisle	England
United Kingdom	Cheltenham General Hospital	Cheltenham	England
United Kingdom	Essex County Hospital	Colchester	England
United Kingdom	Ninewells Hospital and Medical School	Dundee	Scotland
United Kingdom	Royal Devon and Exeter Hospital	Exeter	England
United Kingdom	Royal Infirmary - Castle	Glasgow	Scotland
United Kingdom	Diana Princess of Wales Hospital	Grimsby	England
United Kingdom	St. Luke's Cancer Centre at Royal Surrey County Hospital	Guildford	England
United Kingdom	Huddersfield Royal Infirmary	Huddersfield, West Yorks	England
United Kingdom	Princess Royal Hospital	Hull	England
United Kingdom	Ipswich Hospital NHS Trust	Ipswich	England
United Kingdom	Royal Lancaster Infirmary	Lancaster	England
United Kingdom	Cookridge Hospital at Leeds Teaching Hospital NHS Trust	Leeds	England
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Charing Cross Hospital	London	England
United Kingdom	Guy's and St. Thomas' Hospitals NHS Foundation Trust	London	England
United Kingdom	St. George's Hospital	London	England
United Kingdom	Clatterbridge Centre for Oncology NHS Trust	Merseyside	England
United Kingdom	South Tees Hospitals NHS Trust	Middlesbrough, Cleveland	England
United Kingdom	Northern Centre for Cancer Treatment at Newcastle General Hospital	Newcastle-Upon-Tyne	England
United Kingdom	Mount Vernon Hospital	Northwood	England
United Kingdom	Plymouth Hospitals NHS Trust	Plymouth
United Kingdom	Royal Preston Hospital	Preston	England
United Kingdom	Oldchurch Hospital	Romford	England
United Kingdom	Royal South Hants Hospital	Southampton	England
United Kingdom	Singleton Hospital	Swansea	Wales
United Kingdom	Sandwell General Hospital	West Bromwich	England
United Kingdom	Good Hope Hospital Trust	West Midlands	England
United Kingdom	Airedale General Hospital	West Yorkshire	England
United Kingdom	Royal Hampshire County Hospital	Winchester	England
United Kingdom	New Cross Hospital	Wolverhampton	England
United Kingdom	Worcester Royal Hospital	Worcester	England

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Research Campaign Clinical Trials Centre

Country where clinical trial is conducted

United Kingdom,