Study to Determine Effective Dosing of Fondaparinux in Obese Persons

This study has been terminated.
(Funding withdrawn; study closed due to lack of accrual.)
Sponsor:
Collaborator:
American Society for Bariatric Surgery
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00346879
First received: June 28, 2006
Last updated: August 6, 2009
Last verified: August 2009
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Samer Mattar, Principal Investigator, Indiana University
ClinicalTrials.gov Identifier: NCT00346879     History of Changes
Other Study ID Numbers: 0602-26
Study First Received: June 28, 2006
Last Updated: August 6, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Fondaparinux
PENTA
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 August 21, 2014