A Pilot Study Comparing Enoxaparin to Fondaparinux to Prevent Venous Thromboembolism (VTE) in Bariatric Surgical Patients
Information source: Johns Hopkins University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Deep Venous Thrombosis; Pulmonary Embolism
Intervention: Enoxaparin (Drug); Fondaparinux (Drug)
Phase: Phase 0
Status: Recruiting
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s):
Kimberley E Steele, MD, Principal Investigator, Affiliation: Johns Hopkins University
Overall contact:
Kimberley E Steele, M.D., Phone: 410-550-0409, Email: ksteele3@jhmi.edu
Summary
This pilot study is designed to determine the feasibility of conducting a randomized
clinical trial comparing fondaparinux sodium (Arixtra) once daily with enoxaparin (Lovenox®)
twice daily with respect to preventing deep vein thrombosis (DVT) and pulmonary embolism
(PE) after bariatric surgery in obese patients.
Clinical Details
Official title: A Pilot Study to Determine the Feasibility of Conducting a Randomized Clinical Trial Comparing Fondaparinux Sodium (Arixtra) Once Daily With Enoxaparin (Lovenox®) Twice Daily With Respect to Preventing VTE After Bariatric Surgery in Obese Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: To estimate the prevalence of asymptomatic deep venous thrombosis and pulmonary emboli in obese patients undergoing bariatric surgery.
Secondary outcome: To assess the relationship of Anti-factor Xa levels and the occurrence of deep venous thrombosis and pulmonary emboli in bariatric patients receiving standard dose of anticoagulation (enoxaparin/Lovenox or fondaparinux/Arixtra).
Detailed description:
In order to determine the feasibility of such a trial we need to determine the necessary
sample size. In order to determine the necessary sample size, we need to obtain estimates of
the incidence of DVT and the prevalence of PE using MRV in each treatment group. Descriptive
statistics and 95% confidence intervals will be calculated to determine the incidence of DVT
and the prevalence of PE using MRV in obese patients who have received treatment to prevent
DVT and PE associated with bariatric surgery.
Anti-factor Xa levels will be used to help determine if treatments are reaching appropriate
levels.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Men or women 18 years or older.
2. Body mass index (BMI) of 35kg/m2 or greater.
3. Undergoing laparoscopic bariatric surgery, i. e., laparoscopic sleeve gastrectomy,
laparoscopic Roux-en Y gastric bypass or laparoscopic duodenal switch.
Exclusion Criteria:
1. History of previous deep vein thrombosis.
2. History of previous pulmonary emboli.
3. History of documented clotting/coagulation disorder.
4. History of cancer.
5. Weight < 50 kg or > 200 kg or unable to fit in MRI scanner.
6. Presence of metallic foreign bodies
7. Recent history of smoking (within the last year).
8. History of venous stasis disease.
9. History of obesity hypoventilation syndrome.
10. Patients who are unable to lay flat for extended periods of time or are
claustrophobic.
11. Patients who have a pacemaker, an implanted defibrillator or certain other implanted
or electronic or metallic devices (implanted medical or metallic devices, shrapnel,
or metal).
12. History of hypersensitivity reaction to anticoagulation products.
13. History of HIT (Heparin Induced Thrombocytopenia.
14. History of Renal Insufficiency (Creatinine Clearance < 50).
15. Active clinically significant bleeding.
16. Acute bacterial endocarditis.
17. BMI > 60.
18. Patients with metallic foreign body or implant (unable to have an MRV study).
Locations and Contacts
Kimberley E Steele, M.D., Phone: 410-550-0409, Email: ksteele3@jhmi.edu
Johns Hopkins Bayview Medical Center, Baltimore, Maryland 21224, United States; Recruiting
Shelley Adderley, Phone: 410-550-4472, Email: sadderl1@jhmi.edu
Additional Information
Starting date: June 2009
Last updated: November 3, 2010
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