Pharmacokinetics of Low Molecular Weight Heparin in Cancer Patients

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

yair plesser, Shaare Zedek Medical Center

ClinicalTrials.gov Identifier:

NCT00716898

First received: July 9, 2008

Last updated: April 14, 2016

Last verified: April 2016

History of Changes

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 Clots Blood Thinners Body Weight Cancer

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]


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

Show Detailed Description

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	July 9, 2008
Last Updated:	April 14, 2016
Health Authority:	Israel: Ethics Commission

Keywords provided by 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

ClinicalTrials.gov processed this record on September 26, 2016

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