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 @ 9:46 PM
Ignite Modification Date:
2025-12-24 @ 9:46 PM
NCT ID:
NCT01205932
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients aged 20 years or above
* Patients undergoing elective THR (the first replacement of the applicable hip joint)
* Patients' written informed consent to participation after receiving detailed verbal and written information on any study specific procedures in advance
Exclusion Criteria:
* Planned, staged major orthopedic surgery within 3 months prior to elective THR or during this study
* History of clinically significant active bleeding (e.g. intracranial bleeding, gastrointestinal bleeding\*), or high bleeding risk
\*: within 3 months prior to elective THR for gastrointestinal bleeding
* Subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
* Severe impaired renal function (CLCR calculated by Cockcroft-Gault formula: \<30 mL/min)
* Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)
* Ongoing anticoagulant therapy (e.g. warfarin, heparins and Factor Xa inhibitors other than study medication) that cannot be stopped (in the opinion of the investigator/sub investigator)
* Subjects for whom epidural catheters are expected to be left in for longer than 18 hours post-operatively
* Planned intermittent pneumatic compression during treatment period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01205932
Study Brief:
Protocol Section:
NCT01205932