Pharmacokinetics of Low Molecular Weight Heparin in Cancer Patients
Recruitment status was Recruiting
The purpose of the study is to determine the Pharmacokinetics of Low Molecular Weight Heparin (LMWH) in Cancer patients, and compare it to the Pharmacokinetics of LMWH in Patients without cancer. We also intend to detect any correlation between heparanase blood and urine levels and the Pharmacokinetics of LMWH.
Advanced Solid Malignancy
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Pharmacokinetics of Low Molecular Weight Heparin in Cancer Patients Compared to Patients With Unstable Angina Pectoris; The Possible Role of Heparanase|
- Pharmacokinetics of Low Molecular Weight Heparin (LMWH) in Cancer patients [ Time Frame: Interim analysis and at the end of the trial ] [ Designated as safety issue: No ]
- The role of heparanase on the Pharmacokinetics of Low Molecular Weight Heparin (LMWH) in Cancer patients [ Time Frame: End of the study ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||June 2011|
|Estimated Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
A. Patients with pathologically or cytologically confirmed diagnosis of advanced solid malignancy.
B. Venous thromboembolism: Deep vein thrombosis (DVT) confirmed by Doppler ultrasound, or pulmonary embolism confirmed by lung ventilation perfusion scan, or computerized tomography.
C. Treatment with therapeutic dose of low molecular weight heparin. D. No major surgery during the last month before investigation. E. No evidence of major infectious disease. F. Serum creatinine level < 1.5 mg/dl. G. Informed consent
A. Patients with unstable angina pectoris/ atypical chest pain, with no evidence of acute myocardial infarction.
B. Treatment with therapeutic dose of low molecular weight heparin. C. No evidence of VTE. D. No major surgery during the last month before investigation. E. No evidence of major infectious disease. F. No history of malignancy. G. Serum creatinine level < 1.5 mg/dl. H. Informed consent
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00716898
|Contact: Nicola J Nasser, MD, PhDfirstname.lastname@example.org|
|Contact: Alberto Gabizon, MD, PhDemail@example.com|
|Shaare Zedek Medicla Center||Recruiting|
|Jerusalm, Israel, 91031|
|Contact: Nicola J. Nasser, M.D., Ph.D. 972-2-6555361 firstname.lastname@example.org|
|Principal Investigator:||Nicola j nasser, MD, PhD||Shaare Zedek MC|