Adjusted Value of Thromboprophylaxis in Hospitalized Obese Patients: A Comparative Study of Two Regimens of Enoxaparin (ITOHENOX)
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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 |
- 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 ]
- Compare the occurrence of symptomatic venous thrombosis (deep venous thrombosis or pulmonary embolism) and the relevant bleeding events according to the enoxparin 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: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (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 |
Inclusion Criteria:
- Patient aged ≥ 18 ans.
- Signed consentment
- Obésity définied by a BMI value ≥ 30 kg/m2.
Hospitalized for :
acute medical affection such as :
- congestive heart failure (stade III or IV NYHA),
- severe respiratory disease,
- Infectious disease or acute rhumatologic 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, myéloproliférative syndrome associated with one or more additional risk previuosly cited.
- Affiliation to a welfare system.
Exclusion Criteria:
- Subjects unwilling or unable to comply with study procedures
- History of hypersensitivity to enoxaparin heparin induced thrombocytopenia
- Previous history of heparin induced thrombopenia
- acquired or inherited bleeding diathesis or coagulopathy,
- Platelet count < 50.000 G/L,
- History of clinically significant bleeding
- Severe renal insufficiency with CrCl <30 ml/min (Cockcroft method),
- Pregnancy or breastfeeding
- Women without contraceptive methods
- Severe peripheral arterial disease (Ankle blood pressure <50mm Hg)
- Concomittant anticoagulant therapy
- Severe psychiatric disease
- 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
- Person deprived of liberty by an administrative or judicial decision, or person under legal guardianship person
- Patient participating to a trial or having participated in another medicinal trial within 1 month
Contacts and Locations| Contact: Ygal Benhamou, PHD | +33 2 88 90 14 | ygal.benhamou@chu-rouen.fr |
| France | |
| UH Rouen | Not yet 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 | |
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: | October 15, 2012 |
| 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 June 18, 2013