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:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-25 @ 4:36 AM
NCT ID:
NCT01509118
Eligibility Criteria:
Inclusion Criteria:
* At least 50 years old in men or post-menopause in women
* Patients, who are undergoing standard surgery for fracture of the upper third of the femur, including femoral head, neck, trochanteric and sub-trochanteric fracture and the surgery is planned within 7 days after admission
* Patients, who are eligible for thromboprophylaxis. Such patients will be enrolled only after physician's decision to prescribe rivaroxaban for thromboprophylaxis has been made. The decision is totally based on standard of medical practice.
* Patients, who agree to participate, return to follow-up visits, and who have signed informed consent to participate in the study.
Exclusion Criteria:
* Trauma affecting more than 1 organ system
* Pathological fracture secondary to malignant disease
* Clinically significant bleeding excluding drainage
* Documented congenital or acquired bleeding disorder
* Patients, who have contraindications for thromboprophylaxis or contraindications to take rivaroxaban according to FDA-approved product label
* Patient on oral anticoagulation therapy in the past 7 days
* Pregnancy or breastfeeding
* Patients who are simultaneously participating in a different study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT01509118
Study Brief:
Protocol Section:
NCT01509118