Investigation Into the Therapeutic Dosage of Fondaparinux Sodium, a Medication Used to Prevent Blood Clots in Morbidly Obese Volunteers

NCT00436787 | Completed Phase 2

• 1 other identifier: ART108029
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

Morbidly obese individuals are at high risk for potentially life threatening blood clots around the time of abdominal surgical procedures. Fondaparinux sodium (Arixtra) is an FDA- approved medication used in the prevention of deep venous thrombosis (DVT) at the time of orthopedic or abdominal surgery, as well as for the treatment of DVT and pulmonary embolism (PE). As with many medications, therapeutic dosages have not been fully investigated for the morbidly obese population. Our goal is to study the therapeutic blood levels, after 2 different dosages of the medication are given to morbidly obese volunteers. We will recruit 21 morbidly obese (Body Mass Index (BMI) \> 35) individuals who are in the evaluation process for bariatric surgery. They will be divided into 7 groups: 3 participants with BMI 35 - 39.9, 3 with a BMI of 40 - 49.9, 3 with a BMI of 50 - 59.9, 3 with a BMI \> 60, 3 with a weight of 100 - 149 KG, 3 with a weight of 150 - 199 KG and 3 with a weight of 200 - 249 KG. Participants will be administered two different doses of the medication with a 2-week interval in between, then blood will be drawn in various intervals throughout the next 48 hours to see which dose provides the best therapeutic levels. Participants will be monitored closely for any side effects or complications.

Conditions

Venous Thrombosis; Pulmonary Embolism

Keywords

Anticoagulation Prophylaxis; Venous Thrombosis; Deep Vein Thrombosis; Pulmonary Embolism; Fondaparinux Sodium; Arixtra; Pharmakinetics

Outcome Measures

Primary Outcomes (1)

• The pharmacokinetic properties of fondaparinux sodium in morbidly obese individuals.

Secondary Outcomes (4)

• Comparisons of the pharmacokinetic parameters of morbidly obese participants receiving 2.5 mg or 5 mg dose of fondaparinux sodium with those of healthy normal-weight volunteers established from previous studies.

• Comparison of the pharmacokinetic parameters of the 2.5 mg and 5 mg dosage of fondaparinux sodium.

• Evaluate the effect of BMI and ABW on the pharmacokinetic parameters of the 2.5 mg and 5 mg dosages of fondaparinux sodium.

• Assess the safety of fondaparinux sodium, as measured by defined safety endpoints, and compare the 2 dose groups for differences in the incidence of adverse events (AE).

Interventions

Fondaparinux Sodium DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 19-65 years
• BMI 35-65 Kg/m2
• Pregnancy test Negative on day of study
• Past DVT/PE/MI These patients will not be excluded providing they are not on current therapy with anticoagulants, aspirin, or anti-platelet agents.

You may not qualify if:

• BP ≥ 160/90
• Temperature \> 37.5 0C (99.5 0F)
• Nursing mothers Exclude if nursing
• Pregnancy test Positive on day of study
• Medications Anticoagulants, anti-platelet agents, aspirin, NSAIDs within a month of the study
• Past medical history
• cerebrovascular accident (including TIA within 6 months of the study)
• Diabetic retinopathy proven by fundoscopy
• History of inherited thrombotic/hypercoagulable defect
• Active peptic ulcer disease diagnosed by upper endoscopy
• Known bleeding disorder, thrombophilia
• History of heparin induced thrombocytopenia
• History of bacterial endocarditis
• Known hypersensitivity to fondaparinux
• Ulcerative colitis

Sponsors & Collaborators

• University of Pittsburgh: lead
• GlaxoSmithKline: collaborator

Study Sites (2)

Magee Women's Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Shadyside Medical Building

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism

Interventions

Fondaparinux

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• Ioannis Raftopoulos, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Expanded Access: Yes

Study Record Dates

• First Submitted: February 16, 2007
• First Posted: February 19, 2007
• Study Start: February 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 16, 2008

Record last verified: 2008-05

Locations

US (2)