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

Pulmonary Embolism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00894283
• Other study ID #: NA_00025492
• Status: Completed
• Phase: Early Phase 1
• Start date: June 2009
• Est. completion date: September 2013

Study information

• Verified date: June 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Embolism
• Pulmonary Embolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Drug:
• 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 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the prevalence of asymptomatic deep venous thrombosis and pulmonary emboli in obese patients undergoing bariatric surgery.		2 years
Secondary	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