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

June 17, 2015 updated by: University Hospital, Rouen
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76000
        • UH Rouen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 hours after third Eoxaparin injection

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
All along the study (max 14 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: Ygal BENHAMOU, MD, PHD, Rouen university hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

October 12, 2012

First Submitted That Met QC Criteria

October 15, 2012

First Posted (Estimate)

October 16, 2012

Study Record Updates

Last Update Posted (Estimate)

June 18, 2015

Last Update Submitted That Met QC Criteria

June 17, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/056/HP
  • 2012-001414-42 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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