Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024297
Status:
COMPLETED
Last Update Posted:
2013-08-07
First Post:
2001-09-13
Brief Title:
Warfarin in Preventing Blood Clots in Cancer Patients With Central Venous Catheters
Sponsor:
Cancer Research Campaign Clinical Trials Centre
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multicenter Prospective Randomized Controlled Trial of Thrombosis Prophylaxis With Warfarin in Cancer Patients With Central Venous Catheters
Status:
COMPLETED
Status Verified Date:
2002-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 1400 patients 400 in arm I 700 in arm II and 300 in arm III will be accrued for this study within 2 years
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 1400 patients 400 in arm I 700 in arm II and 300 in arm III will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN50312145 | REGISTRY | ISRCTN International Standard Randomised Controlled Trial Number Register | None |
| CDR0000068909 | REGISTRY | None | None |
| EU-20049 | None | None | None |