Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT01707732
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01707732
Study Brief:
Protocol Section:
NCT01707732