Heparin or Enoxaparin in Patients With Cancer
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|ClinicalTrials.gov Identifier: NCT00004875|
Recruitment Status : Completed
First Posted : July 26, 2004
Last Update Posted : February 21, 2011
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.
|Condition or disease||Intervention/treatment|
|Lymphoma Thromboembolism Unspecified Adult Solid Tumor, Protocol Specific||Drug: enoxaparin Drug: heparin|
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.
|Study Type :||Observational|
|Actual Enrollment :||6 participants|
|Official Title:||Release of TFPI by Anticoagulants in Cancer Patients by Standard or LMW Heparin|
|Study Start Date :||July 1996|
|Actual Primary Completion Date :||March 1999|
|Actual Study Completion Date :||March 1999|
|Standard Heparin||Drug: heparin|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|