Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004875
Status:
COMPLETED
Last Update Posted:
2011-02-21
First Post:
2000-03-07
Brief Title:
Heparin or Enoxaparin in Patients With Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Release of TFPI by Anticoagulants in Cancer Patients by Standard or LMW Heparin
Status:
COMPLETED
Status Verified Date:
2011-02
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 Heparin or enoxaparin may be effective in preventing the formation of blood clots in patients with cancer who are undergoing surgery to remove the tumor
PURPOSE Randomized clinical trial to compare the effectiveness of heparin with that of enoxaparin in patients who have cancer
PURPOSE Randomized clinical trial to compare the effectiveness of heparin with that of enoxaparin in patients who have cancer
Detailed Description:
OBJECTIVES I Determine the patterns of tissue factor pathway inhibitor TFPI release according to tumor type and type of anticoagulation heparin or enoxaparin in patients with cancer II Determine the incidence of portacath clots and its correlation to TFPI releasability in this patient population III Compare these anticoagulation drugs in terms of releasability of TFPI in this patient population
OUTLINE This is a randomized study Patients are stratified according to prior chemotherapy within the past 3 weeks yes vs no Patients are randomized to one of two treatment arms Arm I Patients receive a single dose of standard heparin subcutaneously SQ followed by evaluation of tissue factor pathway inhibitor TFPI response at 5 and 10 minutes post injection Arm II Patients receive a single dose of enoxaparin SQ followed by evaluation of TFPI response as in arm I Patients are followed monthly for 3 months
PROJECTED ACCRUAL A total of 20-200 patients will be accrued for this study over 6 months
OUTLINE This is a randomized study Patients are stratified according to prior chemotherapy within the past 3 weeks yes vs no Patients are randomized to one of two treatment arms Arm I Patients receive a single dose of standard heparin subcutaneously SQ followed by evaluation of tissue factor pathway inhibitor TFPI response at 5 and 10 minutes post injection Arm II Patients receive a single dose of enoxaparin SQ followed by evaluation of TFPI response as in arm I Patients are followed monthly for 3 months
PROJECTED ACCRUAL A total of 20-200 patients 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-G00-1670 | None | None | None |
| NU-96X2 | None | None | None |