Pharmacokinetics of Low Molecular Weight Heparin in Cancer Patients

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2009 by Shaare Zedek Medical Center.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Shaare Zedek Medical Center

ClinicalTrials.gov Identifier:

NCT00716898

First received: July 9, 2008

Last updated: May 29, 2011

Last verified: February 2009

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 Advanced Solid Malignancy


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 Cancer

Drug Information available for: Heparin Dalteparin sodium

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 ]


Estimated Enrollment:	25
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)

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


Ages Eligible for Study:	18 Years and older
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

Contacts


Contact: Nicola J Nasser, MD, PhD	972-2-6555361	nicola.nasser@gmail.com
Contact: Alberto Gabizon, MD, PhD	972-2-6555361	agabizon@szmc.org.il

Locations


Israel
Shaare Zedek Medicla Center	Recruiting
Jerusalm, Israel, 91031
Contact: Nicola J. Nasser, M.D., Ph.D. 972-2-6555361 nicola.nasser@gmail.com

Sponsors and Collaborators

Shaare Zedek Medical Center

Investigators


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

More Information

No publications provided


Responsible Party:	Nicola J. Nasser, M.D., Ph.D., 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:	May 29, 2011
Health Authority:	Israel: Ethics Commission

Keywords provided by Shaare Zedek Medical Center:


Condition Cancer Patients Thrombosis	Unstable Angina Pectoris

Additional relevant MeSH terms:


Angina Pectoris Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Pain Signs and Symptoms Vascular Diseases Dalteparin	Heparin, Low-Molecular-Weight Anticoagulants Cardiovascular Agents Fibrin Modulating Agents Fibrinolytic Agents Hematologic Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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