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

Primary Purpose

Thromboprophylaxis in Hospitalized Obese Patients

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Enoxaparin

About this trial

This is an interventional treatment trial for Thromboprophylaxis in Hospitalized Obese Patients focused on measuring Obesity, thromboprophylaxis, Enoxaparin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UH Rouen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Enoxaparin 40mg/ day

Enoxaparin 60 mg/day

Arm Description

Enoxaparin administrated at the following dose : 40mg/ day

Enoxaparin administrated at the following dose : 60 mg/day

Outcomes

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

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

Full Information

NCT ID

NCT01707732

First Posted

October 12, 2012

Last Updated

June 17, 2015

Sponsor

University Hospital, Rouen

1. Study Identification

Unique Protocol Identification Number

NCT01707732

Brief Title

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

Acronym

ITOHENOX

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Rouen

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thromboprophylaxis in Hospitalized Obese Patients

Keywords

Obesity, thromboprophylaxis, Enoxaparin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

92 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Enoxaparin 40mg/ day

Arm Type

Active Comparator

Arm Description

Enoxaparin administrated at the following dose : 40mg/ day

Arm Title

Enoxaparin 60 mg/day

Arm Type

Experimental

Arm Description

Enoxaparin administrated at the following dose : 60 mg/day

Intervention Type

Drug

Intervention Name(s)

Enoxaparin

Intervention Description

Administration of Enoxaparin

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ygal BENHAMOU, MD, PHD

Organizational Affiliation

Rouen University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

UH Rouen

City

Rouen

ZIP/Postal Code

76000

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

28460259

Citation

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.

Results Reference

derived

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

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