Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006083
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2000-08-03
Brief Title:
Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Phase III Randomized Double-Blind Placebo-Controlled Study to Evaluate the Effects of Fragmin 5000 IU Subcutaneously in Preventing Catheter-Related Complications When Given Daily to Cancer Patients With Central Venous Catheters
Status:
COMPLETED
Status Verified Date:
2012-07
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 The use of dalteparin may be able to prevent complications caused by the use of a catheter to supply chemotherapy to cancer patients It is not yet known if dalteparin is effective in reducing these complications
PURPOSE Randomized phase III trial to determine the effectiveness of dalteparin in preventing catheter-related complications in cancer patients who are receiving chemotherapy through a catheter
PURPOSE Randomized phase III trial to determine the effectiveness of dalteparin in preventing catheter-related complications in cancer patients who are receiving chemotherapy through a catheter
Detailed Description:
OBJECTIVES I Determine if dalteparin will reduce the incidence of clinically significant catheter related complications ie asymptomatic catheter related thrombosis in cancer patients receiving chemotherapy through a central venous catheter
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to treatment center and catheter placement proximal to axilla vs distal to axilla Patients are randomized to one of two treatment arms Arm I Patients receive dalteparin subcutaneously SC daily Arm II Patients receive placebo SC daily Treatment continues for 16 weeks or until catheter removal in the absence of unacceptable toxicity Patients are followed for 30 days
PROJECTED ACCRUAL A total of 345 patients 230 in arm I and 115 in arm II will be accrued for this study over 6 months
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to treatment center and catheter placement proximal to axilla vs distal to axilla Patients are randomized to one of two treatment arms Arm I Patients receive dalteparin subcutaneously SC daily Arm II Patients receive placebo SC daily Treatment continues for 16 weeks or until catheter removal in the absence of unacceptable toxicity Patients are followed for 30 days
PROJECTED ACCRUAL A total of 345 patients 230 in arm I and 115 in arm II will be accrued for this study over 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1822 | None | None | None |
| UCLA-9910055 | None | None | None |
| P-UPJOHN-98-FRAG-076 | None | None | None |