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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT01431456
Eligibility Criteria:
Inclusion Criteria:
Patients \> 18 years and weighing more than 40 kg who are scheduled for primary elective total knee arthroplasty according to the 'joint care program' and want to provided signed informed consent are eligible for the study.
Exclusion Criteria:
* a known inherited or acquired clinically significant active high risk of bleeding or bleeding disorder;
* major surgery, trauma, uncontrolled severe arterial hypertension, or myocardial infarction within the last 3 months;
* history of acute intracranial disease or hemorrhagic stroke;
* gastrointestinal or urogenital bleeding or ulcer disease within the last 6 months;
* cirrhotic patients with moderate hepatic impairment (aspartate or alanine aminotransferase (AST, ALT) levels higher than 2x the upper limit of the normal range (ULN) within the last month);
* severe renal insufficiency (creatinine clearance \< 30 mL/min);
* treatment with anticoagulants during study drug treatment;
* active malignant disease;
* pregnancy or breastfeeding;
* and unable to give informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
110 Years
Study:
NCT01431456
Study Brief:
Protocol Section:
NCT01431456