Study to Determine Effective Dosing of Fondaparinux in Obese Persons

NCT00346879 | Withdrawn Phase 1 DMC

• 1 other identifier: 0602-26
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Morbid Obesity

Keywords

fondaparinux for prevention of blood clots

Outcome Measures

Primary Outcomes (1)

• Compare peak anti-Xa activity between fixed dose and weight-based dose of fondaparinux

  5 days

Secondary Outcomes (2)

• Determine safety of fondaparinux in the two treatment groups

  5 days

• Determine if anti-Xa activity accumulates

  5 days

Interventions

fondaparinux DRUG

Single 2.5 mg dose of fondaparinux or weight-based 0.03 mg/Kg dose of fondaparinux

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Indiana University School of Medicine: lead
• American Society for Bariatric Surgery: collaborator

Study Sites (1)

Clarian Bariatric Center

Indianapolis, Indiana, 46278, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Fondaparinux

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• Samer Mattar, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 28, 2006
• First Posted: June 30, 2006
• Study Start: August 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: February 23, 2016

Record last verified: 2016-02

Locations

US (1)