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Study to Determine Effective Dosing of Fondaparinux in Obese Persons

This study has been withdrawn prior to enrollment.
(Funding withdrawn; study closed due to lack of accrual.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00346879
First Posted: June 30, 2006
Last Update Posted: February 23, 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.
Collaborator:
American Society for Bariatric Surgery
Information provided by:
Indiana University
  Purpose
This is a prospective open-label study comparing two dosing regimens of fondaparinux, which is used to prevent deep vein thrombosis, in morbidly obese volunteers.

Condition Intervention Phase
Morbid Obesity Drug: fondaparinux Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thromboprophylaxis in the Morbidly Obese With Weight Based Dosing of Fondaparinux: A Pharmacodynamic Study

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Compare peak anti-Xa activity between fixed dose and weight-based dose of fondaparinux [ Time Frame: 5 days ]

Secondary Outcome Measures:
  • Determine safety of fondaparinux in the two treatment groups [ Time Frame: 5 days ]
  • Determine if anti-Xa activity accumulates [ Time Frame: 5 days ]

Enrollment: 0
Study Start Date: August 2006
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: fondaparinux
    Single 2.5 mg dose of fondaparinux or weight-based 0.03 mg/Kg dose of fondaparinux
Detailed Description:
The incidence of obesity is growing at an alarming pace and has reached epidemic proportions. Subjects who are more than 100 pounds over their ideal body weight are classified as being morbidly obese and are considered to carry a high risk for multiple chronic medical conditions that impact quality of life and shorten life span. As a result of obesity, these individuals are also at a higher risk for developing life-threatening blood clots. Such risk is further elevated with exposure of obese subjects to the stress of surgery. In fact, the most common cause of death after major surgery in morbidly obese subjects is the migration of blood clots to the lung and heart. With the current rise in popularity of weight loss surgery, it has become imperative that we identify a medication that is safe and effective in preventing the formation of blood clots. Fondaparinux has the potential for being an effective anti-clotting drug. It is superior to other similar drugs because it is completely utilized by the body, and has a more predictable action. The problem, however, is that the recommended doses for fondaparinux were obtained after studies on lean individuals. This is a fixed dose that is administered universally, regardless of the size of the subject. Presently, we have no information on what the recommended doses should be for morbidly obese subjects, who are in the most need for effective anti-clotting medication. This study will attempt to determine whether a fixed dose or a weight-related dose is appropriate for morbidly obese subjects, and also investigate the safety of administering weight-based dosing to these individuals.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Age 19-65 BMI: 35-65 Negative pregnancy test on day of study

Exclusion Criteria:

- Blood Pressure < or = to 160/90 Temperature > 37.5 C (99.5 F) Nursing a baby Positive pregnancy test on day of study. Medications: History of regular treatment with anticoagulants or any anti-platelet agents including aspirin and other NSAIDS; use of aspirin or other NSAIDS within 1 month of study.

Past Medical History:

Cerebrovascular accident (including transient ischemic attacks) within 6 months of study.

Diabetic retinopathy as documented by positive fundoscopy in previous 3 months. Active peptic ulcer disease, by EGD or Ba meal, within 3 months of study. Known bleeding disorder. Known thrombophilia History of heparin induced thrombocytopenia. History of bacterial endocarditis. Known hypersensitivity to fondaparinux. Ulcerative colitis. History of GI bleeding History of hematuria Recent surgery (in previous 3 months). Recent trauma - road traffic accident (previous 3 months).

Laboratory Values:

Platelet count < or = to 100,000. Hemoglobin <12g/dl - women or <14g/dl - men. Prothrombin time > 13s Activated partial thromboplastin time (APTT) > 35s Liver function test parameters: ALT > 60u/L, AST > 40u/L, γ-GT >85u/L, Alkaline phosphatase >251 u/L or total bilirubin > 1.3 mg/dl.

Estimated urinary creatinine clearance < 50 mls/min. Hematuria on urine dipstick.

  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): NCT00346879


Locations
United States, Indiana
Clarian Bariatric Center
Indianapolis, Indiana, United States, 46278
Sponsors and Collaborators
Indiana University School of Medicine
American Society for Bariatric Surgery
Investigators
Principal Investigator: Samer Mattar, MD Indiana University
  More Information

Responsible Party: Samer Mattar, Principal Investigator, Indiana University
ClinicalTrials.gov Identifier: NCT00346879     History of Changes
Other Study ID Numbers: 0602-26
First Submitted: June 28, 2006
First Posted: June 30, 2006
Last Update Posted: February 23, 2016
Last Verified: February 2016

Keywords provided by Indiana University:
fondaparinux for prevention of blood clots

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Fondaparinux
PENTA
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents