A Pilot Study Comparing Enoxaparin to Fondaparinux to Prevent Venous Thromboembolism (VTE) in Bariatric Surgical Patients
This study has been completed.
Sponsor:
Johns Hopkins University
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Kimberley Steele, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00894283
First received: May 5, 2009
Last updated: August 6, 2014
Last verified: August 2014
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Deep Venous Thrombosis Pulmonary Embolism |
Drug: Enoxaparin Drug: Fondaparinux |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Johns Hopkins University:
Primary Outcome Measures:
- To estimate the prevalence of asymptomatic deep venous thrombosis and pulmonary emboli in obese patients undergoing bariatric surgery. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 198 |
| Study Start Date: | June 2009 |
| Study Completion Date: | September 2013 |
| Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00894283
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Kimberley Steele, Assistant Professor of Surgery, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00894283 History of Changes |
| Other Study ID Numbers: | NA_00025492 |
| Study First Received: | May 5, 2009 |
| Last Updated: | August 6, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Johns Hopkins University:
|
DVT PE MRV bariatric surgery |
Additional relevant MeSH terms:
|
Pulmonary Embolism Venous Thrombosis Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Thrombosis Vascular Diseases Fondaparinux |
PENTA Anticoagulants Cardiovascular Agents Fibrin Modulating Agents Fibrinolytic Agents Hematologic Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015