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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: GlaxoSmithKline
• Treatments: Fondaparinux; PENTA

Criteria

INCLUSION

1. Age 19-65 years

2. BMI 35-65 Kg/m2

3. Pregnancy test Negative on day of study

4. Past DVT/PE/MI These patients will not be excluded providing they are not on current therapy with anticoagulants, aspirin, or anti-platelet agents.

EXCLUSION

1. BP ≥ 160/90

2. Temperature > 37.5 0C (99.5 0F)

3. Nursing mothers Exclude if nursing

4. Pregnancy test Positive on day of study

5. Medications Anticoagulants, anti-platelet agents, aspirin, NSAIDs within a month of the study

Past medical history

1. cerebrovascular accident (including TIA within 6 months of the study)

2. Diabetic retinopathy proven by fundoscopy

3. History of inherited thrombotic/hypercoagulable defect

4. Active peptic ulcer disease diagnosed by upper endoscopy

5. Known bleeding disorder, thrombophilia

6. History of heparin induced thrombocytopenia

7. History of bacterial endocarditis

8. Known hypersensitivity to fondaparinux

9. Ulcerative colitis

10. History of GI bleeding

11. History of hematuria

12. Recent surgery (last 3 months)

13. Recent trauma (last 3 months)

Laboratory values

1. Platelet count ≤ 100,000 mm3

2. Hemoglobin < 12 g/dL (women), or < 14 g/dL (men)

3. Prothrombin time > 13 sec

4. PTT > 35 sec

5. ALT 3xULN and bilirubin 1.5xULN (>35% direct); or ALT 5xULN; or ALT 3xULN if associated with the appearance or worsening of hepatitis symptoms or rash

6. Estimated urinary creatinine clearance ≤ 50 ml/min

7. Hematuria on urine dipstick