A Pilot Study Comparing Enoxaparin to Fondaparinux to Prevent Venous Thromboembolism (VTE) in Bariatric Surgical Patients
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ClinicalTrials.gov Identifier: NCT00894283 |
Recruitment Status
:
Completed
First Posted
: May 6, 2009
Last Update Posted
: August 7, 2014
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Condition or disease | Intervention/treatment | Phase |
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Deep Venous Thrombosis Pulmonary Embolism | Drug: Enoxaparin Drug: Fondaparinux | Early Phase 1 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 198 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
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 Start Date : | June 2009 |
Actual Primary Completion Date : | September 2013 |
Actual Study Completion Date : | September 2013 |
Arm | Intervention/treatment |
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Active Comparator: 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.
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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.
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Active Comparator: 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.
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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.
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- To estimate the prevalence of asymptomatic deep venous thrombosis and pulmonary emboli in obese patients undergoing bariatric surgery. [ Time Frame: 2 years ]
- 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). [ Time Frame: 2 years ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men or women 18 years or older.
- Body mass index (BMI) of 35kg/m2 or greater.
- Undergoing laparoscopic bariatric surgery, i.e., laparoscopic sleeve gastrectomy, laparoscopic Roux-en Y gastric bypass or laparoscopic duodenal switch.
Exclusion Criteria:
- History of previous deep vein thrombosis.
- History of previous pulmonary emboli.
- History of documented clotting/coagulation disorder.
- History of cancer.
- Weight < 50 kg or > 200 kg or unable to fit in MRI scanner.
- Presence of metallic foreign bodies
- Recent history of smoking (within the last year).
- History of venous stasis disease.
- History of obesity hypoventilation syndrome.
- Patients who are unable to lay flat for extended periods of time or are claustrophobic.
- 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).
- History of hypersensitivity reaction to anticoagulation products.
- History of HIT (Heparin Induced Thrombocytopenia.
- History of Renal Insufficiency (Creatinine Clearance < 50).
- Active clinically significant bleeding.
- Acute bacterial endocarditis.
- BMI > 60.
- Patients with metallic foreign body or implant (unable to have an MRV study).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00894283
United States, Maryland | |
Johns Hopkins Bayview Medical Center | |
Baltimore, Maryland, United States, 21224 |
Principal Investigator: | Kimberley E Steele, MD | Johns Hopkins University |
Responsible Party: | Kimberley Steele, Assistant Professor of Surgery, Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00894283 History of Changes |
Other Study ID Numbers: |
NA_00025492 |
First Posted: | May 6, 2009 Key Record Dates |
Last Update Posted: | August 7, 2014 |
Last Verified: | August 2014 |
Keywords provided by Kimberley Steele, Johns Hopkins University:
DVT PE MRV bariatric surgery |
Additional relevant MeSH terms:
Thrombosis Embolism Venous Thromboembolism Pulmonary Embolism Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thromboembolism Lung Diseases Respiratory Tract Diseases |
Fondaparinux PENTA Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents |