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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
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Kimberley Steele, Johns Hopkins University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Deep Venous Thrombosis Pulmonary Embolism Drug: Enoxaparin Drug: Fondaparinux Early Phase 1

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 Design
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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

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Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. To estimate the prevalence of asymptomatic deep venous thrombosis and pulmonary emboli in obese patients undergoing bariatric surgery. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
GlaxoSmithKline
Investigators
Principal Investigator: Kimberley E Steele, MD Johns Hopkins University
More Information
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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