Pharmacokinetics of Low Molecular Weight Heparin in Cancer Patients
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ClinicalTrials.gov Identifier: NCT00716898 |
Recruitment Status
:
Completed
First Posted
: July 16, 2008
Last Update Posted
: April 15, 2016
|
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Condition or disease |
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Cancer Thrombosis Angina Pectoris |

Study Type : | Observational |
Actual Enrollment : | 25 participants |
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 |
Study Start Date : | February 2009 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | June 2011 |
Group/Cohort |
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1
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 |
2
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 |
- Pharmacokinetics of Low Molecular Weight Heparin (LMWH) in Cancer patients [ Time Frame: Interim analysis and at the end of the trial ]
- The role of heparanase on the Pharmacokinetics of Low Molecular Weight Heparin (LMWH) in Cancer patients [ Time Frame: End of the study ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Treatment with therapeutic dose of low molecular weight heparin
- Serum creatinine level < 1.5 mg/dl.
Exclusion Criteria:
- major surgery during the last month before investigation
- evidence of major infectious disease

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): NCT00716898
Israel | |
Shaare Zedek Medicla Center | |
Jerusalm, Israel, 91031 |
Principal Investigator: | Nicola j nasser, MD, PhD | Shaare Zedek MC |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | yair plesser, study manager, Shaare Zedek Medical Center |
ClinicalTrials.gov Identifier: | NCT00716898 History of Changes |
Other Study ID Numbers: |
Nasser-2008-1CTIL |
First Posted: | July 16, 2008 Key Record Dates |
Last Update Posted: | April 15, 2016 |
Last Verified: | April 2016 |
Keywords provided by yair plesser, Shaare Zedek Medical Center:
Condition Cancer Patients Thrombosis |
Unstable Angina Pectoris |
Additional relevant MeSH terms:
Thrombosis Angina Pectoris Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Chest Pain Pain Neurologic Manifestations Nervous System Diseases Myocardial Ischemia |
Heart Diseases Signs and Symptoms Calcium heparin Heparin Heparin, Low-Molecular-Weight Dalteparin Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |