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

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

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Key information

Conditions

Thromboprophylaxis in Hospitalized Obese Patients Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UH Rouen

Rouen, 76000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient aged ≥ 18 ans.
Signed inform consent
Obesity defined by a BMI value ≥ 30 kg/m2.
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.
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)
Concomitant 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

Treatment and study plan

Enoxaparin

Drug

Administration of Enoxaparin

Primary outcomes

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 outcomes

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)

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: ITOHENOX

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Oct 16, 2012
Registry last updated: Jun 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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