Pharmacokinetics of Low Molecular Weight Heparin in Cancer Patients

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00716898

First Posted: July 16, 2008

Last Update Posted: April 15, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

yair plesser, Shaare Zedek Medical Center

Purpose

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.

Condition
Cancer Thrombosis Angina Pectoris


Study Type:	Observational
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

Resource links provided by NLM:

MedlinePlus related topics: Angina Blood Thinners Body Weight

Drug Information available for: Heparin Heparin sodium

U.S. FDA Resources

Further study details as provided by yair plesser, Shaare Zedek Medical Center:

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 ]


Enrollment:	25
Study Start Date:	February 2009
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
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

Groups/Cohorts

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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Eligibility

Information from the National Library of Medicine

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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

Study Population

patients treated at SZMC

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations


Israel
Shaare Zedek Medicla Center
Jerusalm, Israel, 91031

Sponsors and Collaborators

Shaare Zedek Medical Center

Investigators


Principal Investigator:	Nicola j nasser, MD, PhD	Shaare Zedek MC

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nasser NJ, Na'amad M, Weinberg I, Gabizon AA. Pharmacokinetics of low molecular weight heparin in patients with malignant tumors. Anticancer Drugs. 2015 Jan;26(1):106-11. doi: 10.1097/CAD.0000000000000176.


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 Submitted:	July 9, 2008
First Posted:	July 16, 2008
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

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