Clinical trial NCT00894283: Comparing Enoxaparin to Fondaparinux to Prevent Venous Thromboembolism (VTE) in Bariatric Surgical Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Deep Venous Thrombosis
Pulmonary Embolism
Keywords: DVT
PE
MRV
bariatric surgery
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2009-05-06
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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.

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 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).

Primary outcomes:
measure: To estimate the prevalence of asymptomatic deep venous thrombosis and pulmonary emboli in obese patients undergoing bariatric surgery.
timeFrame: 2 years
Secondary outcomes:
measure: 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).
timeFrame: 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Kimberley E Steele, MD
role: PRINCIPAL_INVESTIGATOR
References: