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Release of TFPI by Anticoagulants in Cancer Patients by Standard or LMW Heparin
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Veterans Affairs Medical Center - Chicago (Lakeside)
Chicago, Illinois, United States
Evanston Northwestern Health Care
Evanston, Illinois, United States
Start Date
July 1, 1996
Primary Completion Date
March 1, 1999
Completion Date
March 1, 1999
Last Updated
February 21, 2011
6
ACTUAL participants
enoxaparin
DRUG
heparin
DRUG
Lead Sponsor
Northwestern University
Collaborators
NCT07388563
NCT05529069
Data Source & Attribution
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