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 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT02043132
Eligibility Criteria:
Inclusion Criteria:
1. Patients undergoing scheduled primary reverse total shoulder arthroplasty performed by J. Michael Wiater, MD.
2. Patients age 18 and older
Exclusion Criteria:
1. Pregnant\* or breast-feeding women
2. Allergy to tranexamic acid
3. Acquired disturbances of color vision
4. Use of estrogen containing medications (i.e. oral contraceptive pills)
5. Hormone replacement therapy
6. Preoperative anemia \[Hemoglobin (Hb) \< 11g/dL in females, Hb \< 12 g/dL in males\]
7. Refusal of blood products
8. Preoperative use of anticoagulant therapy within 5 days prior to surgery
1. Coumadin
2. Heparin
3. Low molecular weight heparin
4. Factor Xa inhibitors
9. Thrombin inhibitors
10. Coagulopathy
11. Thrombophilia
12. Antithrombin deficiency
13. Factor V Leiden
14. Antiphospholipid Syndrome
15. Protein C and S deficiency
16. History of heparin induced thrombocytopenia
17. Sickle cell anemia
18. Myeloproliferative disorders
19. Platelet \< 150,00 mm3
20. International Normalized Ratio (INR) \> 1.4
21. Partial Thromboplastin Time (PTT) \> 1.4 times normal
22. A history of arterial or venous thromboembolism
23. Cerebral Vascular Accident
24. Deep Vein Thrombosis
25. Pulmonary Embolism
26. Subarachnoid hemorrhage
27. Active intravascular clotting
28. Major comorbidities
29. Coronary artery disease (New York Heart Association Class III or IV)
30. Previous MI
31. Severe pulmonary disease (FEV \<50% normal)
32. Plasma creatinine \> 115 μmol/L in males, \> 100 μmol/L in females, or hepatic failure)
34\. Participation in another clinical trial 35. \*All women of child bearing potential must have a negative serum or urine pregnancy test.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02043132
Study Brief:
Protocol Section:
NCT02043132