Heparin or Enoxaparin in Patients With Cancer
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.
Unspecified Adult Solid Tumor, Protocol Specific
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Release of TFPI by Anticoagulants in Cancer Patients by Standard or LMW Heparin|
|Study Start Date:||July 1996|
|Study Completion Date:||March 1999|
|Primary Completion Date:||March 1999 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004875
|United States, Illinois|
|Veterans Affairs Medical Center - Chicago (Lakeside)|
|Chicago, Illinois, United States, 60611|
|Evanston Northwestern Health Care|
|Evanston, Illinois, United States, 60201|
|Study Chair:||Hau C. Kwaan, MD||Veterans Affairs Medical Center - Lakeside Chicago|