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Adjusted Value of Thromboprophylaxis in Hospitalized Obese Patients: A Comparative Study of Two Regimens of Enoxaparin (ITOHENOX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01707732
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : June 18, 2015
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:
Venous thromboembolism (VTE), deep vein thrombosis (DVT) or pulmonary embolism (PE) is a common medical condition encountered during hospitalization in a medical environment. The use of thromboprophylaxis with Low Molecular Weight Heparin (LMWH) or fondaparinux has reduced more than 50% relative risk of thromboembolic complications.However, while obesity defined by a body mass index (BMI) greater than 30 kg/m2, is a major risk factor for venous thrombotic events, data on obese patients are limited. In fact, less than 20% of patients included in the three major studies of preventive medicine had a BMI ≥ 30 kg/m2 and most studies specific to the obese population comes from a series of bariatric surgery patients or orthopedic surgery. The main results of this series show regarding the obese population a decrease of the anti-Xa activity during the administration of a standard dose of enoxaparin (40 mg / d). However, no specific recommendation in this population has not been published to date and therefore,the dosages currently used are the same regardless of the patient's weight. In this context, the use in obese patients hospitalized in a medical environment a stronger dosage of enoxaparin (60 mg / d) compared to the standard dose of 40 mg / day, could get rates anti-Xa activity levels more consistent with the treatment required, and thus reduce the risk for thromboembolic complications in these patients

Condition or disease Intervention/treatment Phase
Thromboprophylaxis in Hospitalized Obese Patients Drug: Enoxaparin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Adjusted Value of Thromboprophylaxis in Hospitalized Obese Patients: A Comparative Study of Two Regimens of Enoxaparin
Study Start Date : November 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Enoxaparin 40mg/ day
Enoxaparin administrated at the following dose : 40mg/ day
Drug: Enoxaparin
Administration of Enoxaparin

Experimental: Enoxaparin 60 mg/day
Enoxaparin administrated at the following dose : 60 mg/day
Drug: Enoxaparin
Administration of Enoxaparin

Primary Outcome Measures :
  1. Evaluate the anti- Xa activity between a standard treatment by Enoxaparin (40mg/ day) and an adapted dose of enoxaparin (60 mg/day) for thromboprophylaxis in obese patients hospitalized [ Time Frame: 3 hours after third Eoxaparin injection ]

Secondary Outcome Measures :
  1. Compare the occurrence of symptomatic venous thrombosis (deep venous thrombosis or pulmonary embolism) and the relevant bleeding events according to the enoxaparin treatments [ Time Frame: All along the study (max 14 days) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient aged ≥ 18 ans.
  2. Signed inform consent
  3. Obesity defined by a BMI value ≥ 30 kg/m2.
  4. Hospitalized for :

    • acute medical affection such as :

      • congestive heart failure (stage III or IV NYHA),
      • severe respiratory disease,
      • Infectious disease or acute rheumatologic disorder or inflammatory bowel disease with one or more additional risk factors, including active cancer, previous VTE, age > 75 y-o, estrogen therapy, chronic heart failure or chronic respiratory disease
    • or recent myocardial infarction(< 6 weeks), recent stroke with hemiparesis (< 15 days), previous VTE, myeloproliferative syndrome associated with one or more additional risk previously cited.
  5. Affiliation to a welfare system.

Exclusion Criteria:

  1. Subjects unwilling or unable to comply with study procedures
  2. History of hypersensitivity to enoxaparin heparin induced thrombocytopenia
  3. Previous history of heparin induced thrombopenia
  4. acquired or inherited bleeding diathesis or coagulopathy,
  5. Platelet count < 50.000 G/L,
  6. History of clinically significant bleeding
  7. Severe renal insufficiency with CrCl <30 ml/min (Cockcroft method),
  8. Pregnancy or breastfeeding
  9. Women without contraceptive methods
  10. Severe peripheral arterial disease (Ankle blood pressure <50mm Hg)
  11. Concomitant anticoagulant therapy
  12. Severe psychiatric disease
  13. History of disease or psychological or sensory anomaly susceptible to prevent the subject to understand indeed the conditions required for his participation to the protocol or preventing him from giving its enlightened consent
  14. Person deprived of liberty by an administrative or judicial decision, or person under legal guardianship person
  15. Patient participating to a trial or having participated in another medicinal trial within 1 month

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 identifier (NCT number): NCT01707732

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UH Rouen
Rouen, France, 76000
Sponsors and Collaborators
University Hospital, Rouen
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Principal Investigator: Ygal BENHAMOU, MD, PHD Rouen University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital, Rouen Identifier: NCT01707732    
Other Study ID Numbers: 2012/056/HP
2012-001414-42 ( EudraCT Number )
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: June 18, 2015
Last Verified: June 2015
Keywords provided by University Hospital, Rouen:
Additional relevant MeSH terms:
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Nutrition Disorders
Body Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action