Back to resultsComparing Enoxaparin to Fondaparinux to Prevent Venous Thromboembolism (VTE) in Bariatric Surgical Patients
Primary Purpose
Deep Venous Thrombosis, Pulmonary Embolism
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Enoxaparin
Fondaparinux
Sponsored by
About this trial
This is an interventional prevention trial for Deep Venous Thrombosis focused on measuring DVT, PE, MRV, bariatric surgery
Eligibility Criteria
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).
Sites / Locations
- Johns Hopkins Bayview Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Enoxaparin
Fondaparinux
Arm Description
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 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.
Outcomes
Primary Outcome Measures
To estimate the prevalence of asymptomatic deep venous thrombosis and pulmonary emboli in obese patients undergoing bariatric surgery.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT00894283
First Posted
May 5, 2009
Last Updated
June 5, 2019
Sponsor
Johns Hopkins University
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00894283
Brief Title
Comparing Enoxaparin to Fondaparinux to Prevent Venous Thromboembolism (VTE) in Bariatric Surgical Patients
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 Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Venous Thrombosis, Pulmonary Embolism
Keywords
DVT, PE, MRV, bariatric surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
198 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enoxaparin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Fondaparinux
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Fondaparinux
Intervention Description
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 Measure Information:
Title
To estimate the prevalence of asymptomatic deep venous thrombosis and pulmonary emboli in obese patients undergoing bariatric surgery.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberley E Steele, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparing Enoxaparin to Fondaparinux to Prevent Venous Thromboembolism (VTE) in Bariatric Surgical Patients
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