Pharmacokinetics of Low Molecular Weight Heparin in Cancer Patients
This study has been completed.
Information provided by (Responsible Party):
yair plesser, Shaare Zedek Medical Center
First received: July 9, 2008
Last updated: April 14, 2016
Last verified: April 2016
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.
||Observational Model: Case Control
Time Perspective: Prospective
||Pharmacokinetics of Low Molecular Weight Heparin in Cancer Patients Compared to Patients With Unstable Angina Pectoris; The Possible Role of Heparanase
Primary Outcome Measures:
- Pharmacokinetics of Low Molecular Weight Heparin (LMWH) in Cancer patients [ Time Frame: Interim analysis and at the end of the trial ]
Secondary Outcome Measures:
- The role of heparanase on the Pharmacokinetics of Low Molecular Weight Heparin (LMWH) in Cancer patients [ Time Frame: End of the study ]
| Study Start Date:
| Study Completion Date:
| 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
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
patients treated at SZMC
- Treatment with therapeutic dose of low molecular weight heparin
- Serum creatinine level < 1.5 mg/dl.
- major surgery during the last month before investigation
- evidence of major infectious disease
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00716898
|Shaare Zedek Medicla Center
|Jerusalm, Israel, 91031 |
Shaare Zedek Medical Center
||Nicola j nasser, MD, PhD
||Shaare Zedek MC
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
||yair plesser, study manager, Shaare Zedek Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 9, 2008
||April 14, 2016
Keywords provided by Shaare Zedek Medical Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 28, 2017
Embolism and Thrombosis
Nervous System Diseases
Signs and Symptoms
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action