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

NCT01707732 | Completed Phase 3

• 2 other identifiers: 2012/056/HP2012-001414-42
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Conditions

Thromboprophylaxis in Hospitalized Obese Patients

Keywords

Obesity; thromboprophylaxis; Enoxaparin

Outcome Measures

Primary Outcomes (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

  3 hours after third Eoxaparin injection

Secondary Outcomes (1)

• Compare the occurrence of symptomatic venous thrombosis (deep venous thrombosis or pulmonary embolism) and the relevant bleeding events according to the enoxaparin treatments

  All along the study (max 14 days)

Study Arms (2)

Enoxaparin 40mg/ day

ACTIVE COMPARATOR

Enoxaparin administrated at the following dose : 40mg/ day

Drug: Enoxaparin

Enoxaparin 60 mg/day

EXPERIMENTAL

Enoxaparin administrated at the following dose : 60 mg/day

Drug: Enoxaparin

Interventions

Enoxaparin DRUG

Administration of Enoxaparin

Enoxaparin 40mg/ day; Enoxaparin 60 mg/day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

UH Rouen

Rouen, 76000, France

Location

Related Publications (1)

• Miranda S, Le Cam-Duchez V, Benichou J, Donnadieu N, Barbay V, Le Besnerais M, Delmas FX, Cuvelier A, Levesque H, Benhamou Y, Armengol G. Adjusted value of thromboprophylaxis in hospitalized obese patients: A comparative study of two regimens of enoxaparin: The ITOHENOX study. Thromb Res. 2017 Jul;155:1-5. doi: 10.1016/j.thromres.2017.04.011. Epub 2017 Apr 12.

  PMID: 28460259 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Ygal BENHAMOU, MD, PHD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2012
• First Posted: October 16, 2012
• Study Start: November 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 18, 2015

Record last verified: 2015-06

Locations

FR (1)