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 @ 2:50 PM
Ignite Modification Date:
2025-12-24 @ 2:50 PM
NCT ID:
NCT00767559
Eligibility Criteria:
Inclusion Criteria:
1. Planned for elective arthroplasty for knee and hip disease.
2. Over 20 years of age.
3. Normal baseline platelet count, prothrombin and partial thromboplastin times.
4. Signed consent.
Exclusion Criteria:
1. Surgery for acute fracture (\< 4 weeks), septic joint, or extraction arthroplasty.
2. Patients with personal history of TED, or documented hypercoagulation disease.
3. Increased risk of hemorrhage, as from active gastric ulcer, or bleeding diathesis; or persistent intestinal or urinary tract bleed within the last year.
4. Hemorrhagic stroke; brain, spinal, or ophthalmologic surgery in previous 6 months.
5. Liver enzymes or bilirubin greater than 2 x normal.
6. Decreased renal function with GFR \< 30ml/min. (24-27)
7. Cancer in last 1 year, other than localized cancers of the skin.
8. Requires chronic anticoagulation with warfarin or heparins.
9. Requires chronic platelet function suppressive therapy for coronary or peripheral artery stents..
10. Prior adverse reaction to any of the study drugs.
11. Pregnancy
12. Uncontrolled hypertension
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT00767559
Study Brief:
Protocol Section:
NCT00767559