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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
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Cancer Thrombosis Angina Pectoris

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Study Design

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
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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



Outcome Measures

Primary Outcome Measures :
  1. Pharmacokinetics of Low Molecular Weight Heparin (LMWH) in Cancer patients [ Time Frame: Interim analysis and at the end of the trial ]

Secondary Outcome Measures :
  1. The role of heparanase on the Pharmacokinetics of Low Molecular Weight Heparin (LMWH) in Cancer patients [ Time Frame: End of the study ]

Eligibility Criteria

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):
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