Comparing Enoxaparin to Fondaparinux to Prevent Venous Thromboembolism (VTE) in Bariatric Surgical Patients

Early Phase 1

Completed

• Conditions: Deep Venous Thrombosis; Pulmonary Embolism
• Interventions: Drug: Enoxaparin; Drug: Fondaparinux

• Registration Number: NCT00894283
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study First Submitted: 2009-05-05
• Study First Submitted QC: 2009-05-05
• Study First Posted: 2009-05-06
• Study Start: 2009-06
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-05
• Last Update Posted: 2019-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Enoxaparin	Enoxaparin	Patients will receive enoxaparin 40mg subcutaneously twice daily during perioperative period of bariatric surgery. Patients will be encouraged to ambulate and compression stockings while in bed.
Fondaparinux	Fondaparinux	Fondaparinux 5mg subcutaneously 6 hours following surgery, fondaparinux 5mg subcutaneously once daily during hospitalization. Patients will be encouraged to ambulate and compression stockings while in bed.

Primary Outcome Measures

Name	Time	Method
To estimate the prevalence of asymptomatic deep venous thrombosis and pulmonary emboli in obese patients undergoing bariatric surgery.	2 years

Secondary Outcome Measures

Name	Time	Method
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).	2 years

Trial Locations

Locations (1)

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States