Tranexamic Acid in Reverse Total Shoulder Arthroplasty

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To the Investigators' knowledge, TXA has not been studied in the setting of reverse total shoulder arthroplasty. We propose a double-blinded, randomized, controlled trial comparing perioperative administration of TXA to placebo in the setting of RTSA. The purpose of this study is to examine the efficacy of TXA in reducing overall blood loss and transfusion rates in patients undergoing reverse total shoulder arthroplasty.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: William Beaumont Hospitals
• Treatments: Antifibrinolytic Agents; Molecular Mechanisms of Pharmacological Action; Tranexamic Acid

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.