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 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT02401594
Eligibility Criteria:
Inclusion Criteria:
1. Signed and dated informed consent form,
2. Age ≥ 18 years,
3. Hospitalised for non-major orthopaedic surgery and requiring thromboprophylaxis according to the investigator's judgement on VTE risk such Achilles' repair, hip (except femoral neck and trochanteric fracture), knee, tibial plateau, femur (non femoral head), tibial and ankle fractures and tibial osteotomy, tibial transposition, arthrodesis of leg articulation, ligament repair of the knee or the ankle or any elective orthopaedic limb surgery requiring thromboprophylaxis).
Exclusion Criteria:
1. Major orthopaedic surgery Hip and Knee replacement, femoral neck and trochanteric fractures, spine surgery,
2. Low risk surgery without patient VTE risk: foot surgery (Hallux Valgus), material removal,
3. Delay between hospitalisation and randomisation greater than two days,
4. Women of childbearing potential not using a reliable contraceptive method throughout the study period (a list of reliable contraceptive methods is provided in the accompanying SPM),
5. Women pregnant or breast-feeding during the study period,
6. Body weight less than 50 kg (to avoid bleeding over risk) or over 120 kg,
7. Long term treatment with VKA therapy or NOAC,
8. Concomitant treatment with clopidogrel, prasugrel and ticagrelor,
9. Platelet count \< 100 Giga/L,
10. Documented history of acquired or inherited bleeding disorder (e.g., von Willebrand's disease),
11. Severe renal failure with calculated creatinine clearance (Cockcroft Formula) \< 30 mL/min,
12. Severe hepatic insufficiency with prothrombin time \< 60% or liver impairment associated with coagulation disorders,
13. History of thrombocytopenia,
14. Any other current significant medical condition that might interfere with treatment evaluation according to the investigator's judgement,
15. Known hypersensitivity or other severe reaction to any component of the investigational medicinal product(s),
16. Participation in another clinical study involving an investigational medicinal product within 30 days prior to inclusion or concomitantly with this study,
17. Active bleeding or contraindication to anticoagulant therapy
18. Chronic alcoholic intoxication,
19. Anticipated poor compliance of subject with study procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02401594
Study Brief:
Protocol Section:
NCT02401594