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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:

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

  Show Detailed Description

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

ClinicalTrials.gov processed this record on May 21, 2013