A Pilot Study Comparing Enoxaparin to Fondaparinux to Prevent Venous Thromboembolism (VTE) in Bariatric Surgical Patients - Full Text View

Sponsor:	Johns Hopkins University
Collaborator:	GlaxoSmithKline
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00894283

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:

MedlinePlus related topics: Deep Vein Thrombosis Obesity Pulmonary Embolism Weight Loss Surgery

Drug Information available for: Fondaparinux Fondaparinux sodium Enoxaparin Sodium

U.S. FDA Resources

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 ]

Estimated Enrollment:	200
Study Start Date:	June 2009
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00894283

Contacts

Contact: Kimberley E Steele, M.D.	410-550-0409	ksteele3@jhmi.edu
Contact: Shellley Adderley	410-550-4472	sadderl1@jhmi.edu

Locations

United States, Maryland
Johns Hopkins Bayview Medical Center	Recruiting
Baltimore, Maryland, United States, 21224
Contact: Shelley Adderley 410-550-4472 sadderl1@jhmi.edu

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 E. Steele, M.D., Johns Hopkins Bayview Medical Center
ClinicalTrials.gov Identifier:	NCT00894283 History of Changes
Other Study ID Numbers:	NA_00025492
Study First Received:	May 5, 2009
Last Updated:	November 3, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:

DVT
PE
MRV
bariatric surgery

Additional relevant MeSH terms:

Embolism
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Thromboembolism

Fondaparinux
PENTA
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2012