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:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT01651806
Eligibility Criteria:
Inclusion Criteria:
1. Patients must be male or female of any race
2. Ages 18-80 years old
3. Patients must be undergoing an elective, primary knee arthroplasty
4. Patients must be able to understand and willing to cooperate with study procedures
5. Patients must be able to provide written and verbal informed consent
Exclusion Criteria:
1. Allergy or intolerance to the study materials
2. History of a venous thromboembolic event being treated with life-long anticoagulation
3. Patients with a known congenital thrombophilia
4. Patients who have had a venous thromboembolic event within the 12 months preceding surgery
5. History of any substance abuse or dependence within the last 6 months
6. Failure in collecting a required data point during study
7. Those patients not indicated for knee replacement surgery including, pregnant women, those not cleared medically for the procedure and patients without significant radiographic evidence of degenerative joint disease.
8. Patient using autologous blood transfusion
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01651806
Study Brief:
Protocol Section:
NCT01651806