NCT00894283

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Deep Venous Thrombosis
• Pulmonary Embolism

Interventions

Type	Name	Description
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.
DRUG	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.

Timeline

• Start date: 2009-06-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2009-05-06
• Last updated: 2019-06-07

Locations

1 site across 1 country: United States