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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01707732
First received: October 12, 2012
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Thromboprophylaxis in Hospitalized Obese Patients
Drug: Enoxaparin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Adjusted Value of Thromboprophylaxis in Hospitalized Obese Patients: A Comparative Study of Two Regimens of Enoxaparin

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 92
Study Start Date: November 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Enoxaparin 40mg/ day Drug: Enoxaparin
Experimental: Enoxaparin 60 mg/day Drug: Enoxaparin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01707732

Contacts
Contact: Ygal Benhamou, PHD +33 2 88 90 14 ygal.benhamou@chu-rouen.fr

Locations
France
UH Rouen Recruiting
Rouen, France, 76000
Contact: Ygal Benhamou, PHD    +33 2 32 32 88 90 14    ygal.benhamou@chu-rouen.fr   
Principal Investigator: Ygal Benhamou, PHD         
Sponsors and Collaborators
University Hospital, Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01707732     History of Changes
Other Study ID Numbers: 2012/056/HP, 2012-001414-42
Study First Received: October 12, 2012
Last Updated: June 18, 2014
Health Authority: France : ANSM - Agence Nationale de Sécurité du Médicament et des produits de sant&

Keywords provided by University Hospital, Rouen:
Obesity
thromboprophylaxis
Enoxaparin

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
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 July 29, 2014