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

Primary Purpose

Thromboembolism

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
warfarin
Sponsored by
Cancer Research Campaign Clinical Trials Centre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Thromboembolism focused on measuring thromboembolism

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen Elizabeth Hospital at University of Birmingham
  • City Hospital - Birmingham
  • Birmingham Heartlands and Solihull NHS Trust -Teaching
  • Bristol Haematology and Oncology Centre
  • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
  • Cumberland Infirmary
  • Cheltenham General Hospital
  • Essex County Hospital
  • Royal Devon and Exeter Hospital
  • Diana Princess of Wales Hospital
  • St. Luke's Cancer Centre at Royal Surrey County Hospital
  • Huddersfield Royal Infirmary
  • Princess Royal Hospital
  • Ipswich Hospital NHS Trust
  • Royal Lancaster Infirmary
  • Cookridge Hospital at Leeds Teaching Hospital NHS Trust
  • Leeds Cancer Centre at St. James's University Hospital
  • Guy's and St. Thomas' Hospitals NHS Foundation Trust
  • St. George's Hospital
  • Charing Cross Hospital
  • Clatterbridge Centre for Oncology NHS Trust
  • South Tees Hospitals NHS Trust
  • Northern Centre for Cancer Treatment at Newcastle General Hospital
  • Mount Vernon Hospital
  • Royal Preston Hospital
  • Oldchurch Hospital
  • Royal South Hants Hospital
  • Sandwell General Hospital
  • Good Hope Hospital Trust
  • Airedale General Hospital
  • Royal Hampshire County Hospital
  • New Cross Hospital
  • Worcester Royal Hospital
  • Ninewells Hospital and Medical School
  • Royal Infirmary - Castle
  • Velindre Cancer Center at Velinde Hospital
  • Singleton Hospital
  • Plymouth Hospitals NHS Trust

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 13, 2001
Last Updated
August 6, 2013
Sponsor
Cancer Research Campaign Clinical Trials Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00024297
Brief Title
Warfarin in Preventing Blood Clots in Cancer Patients With Central Venous Catheters
Official Title
A Multicenter Prospective Randomized Controlled Trial of Thrombosis Prophylaxis With Warfarin in Cancer Patients With Central Venous Catheters
Study Type
Interventional

2. Study Status

Record Verification Date
December 2002
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cancer Research Campaign Clinical Trials Centre

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thromboembolism
Keywords
thromboembolism

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
warfarin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annie Young
Organizational Affiliation
University Hospital Birmingham
Official's Role
Study Chair
Facility Information:
Facility Name
Queen Elizabeth Hospital at University of Birmingham
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2TT
Country
United Kingdom
Facility Name
City Hospital - Birmingham
City
Birmingham
State/Province
England
ZIP/Postal Code
B18 7QH
Country
United Kingdom
Facility Name
Birmingham Heartlands and Solihull NHS Trust -Teaching
City
Birmingham
State/Province
England
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Cumberland Infirmary
City
Carlisle
State/Province
England
ZIP/Postal Code
CA2 7HY
Country
United Kingdom
Facility Name
Cheltenham General Hospital
City
Cheltenham
State/Province
England
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Facility Name
Essex County Hospital
City
Colchester
State/Province
England
ZIP/Postal Code
C03 3NB
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
State/Province
England
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Diana Princess of Wales Hospital
City
Grimsby
State/Province
England
ZIP/Postal Code
DN33 2BA
Country
United Kingdom
Facility Name
St. Luke's Cancer Centre at Royal Surrey County Hospital
City
Guildford
State/Province
England
ZIP/Postal Code
GU2 5XX
Country
United Kingdom
Facility Name
Huddersfield Royal Infirmary
City
Huddersfield, West Yorks
State/Province
England
ZIP/Postal Code
HD3 3EA
Country
United Kingdom
Facility Name
Princess Royal Hospital
City
Hull
State/Province
England
ZIP/Postal Code
HU8 9HE
Country
United Kingdom
Facility Name
Ipswich Hospital NHS Trust
City
Ipswich
State/Province
England
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
Royal Lancaster Infirmary
City
Lancaster
State/Province
England
ZIP/Postal Code
LA1 4RP
Country
United Kingdom
Facility Name
Cookridge Hospital at Leeds Teaching Hospital NHS Trust
City
Leeds
State/Province
England
ZIP/Postal Code
LS16 6QB
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Guy's and St. Thomas' Hospitals NHS Foundation Trust
City
London
State/Province
England
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
St. George's Hospital
City
London
State/Province
England
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
State/Province
England
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology NHS Trust
City
Merseyside
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
South Tees Hospitals NHS Trust
City
Middlesbrough, Cleveland
State/Province
England
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Northern Centre for Cancer Treatment at Newcastle General Hospital
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Mount Vernon Hospital
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Preston
State/Province
England
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Oldchurch Hospital
City
Romford
State/Province
England
ZIP/Postal Code
RM7 OBE
Country
United Kingdom
Facility Name
Royal South Hants Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO14 0YG
Country
United Kingdom
Facility Name
Sandwell General Hospital
City
West Bromwich
State/Province
England
ZIP/Postal Code
B71 4HJ
Country
United Kingdom
Facility Name
Good Hope Hospital Trust
City
West Midlands
State/Province
England
ZIP/Postal Code
B75 7RR
Country
United Kingdom
Facility Name
Airedale General Hospital
City
West Yorkshire
State/Province
England
ZIP/Postal Code
BD20 6TD
Country
United Kingdom
Facility Name
Royal Hampshire County Hospital
City
Winchester
State/Province
England
ZIP/Postal Code
SO22 5DG
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
State/Province
England
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
Worcester Royal Hospital
City
Worcester
State/Province
England
ZIP/Postal Code
WR5 1DD
Country
United Kingdom
Facility Name
Ninewells Hospital and Medical School
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Royal Infirmary - Castle
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
Velindre Cancer Center at Velinde Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Singleton Hospital
City
Swansea
State/Province
Wales
ZIP/Postal Code
SA 2 8QA
Country
United Kingdom
Facility Name
Plymouth Hospitals NHS Trust
City
Plymouth
ZIP/Postal Code
PL8 8DH
Country
United Kingdom

12. IPD Sharing Statement

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

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