Tranexamic Acid in Reverse Total Shoulder Arthroplasty (TXA)
Shoulder Joint Disease, Complications; Arthroplasty, Intraoperative Complications
About this trial
This is an interventional treatment trial for Shoulder Joint Disease focused on measuring reverse shoulder arthroplasty, Rotator cuff, Orthopedic joint surgery, Total shoulder, Perioperative bleeding, Tranexamic acid, Orthopedic complications, Hemorrhage, Postoperative Hemorrhage, Pathologic Processes, Arthritis, Joint Diseases, Musculoskeletal Diseases, Postoperative Complications, Antifibrinolytic Agents, Fibrin Modulating Agents, Molecular Mechanisms of Pharmacological Action, Pharmacologic Actions, Hemostatics, Coagulants, Hematologic Agents, Therapeutic Uses
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing scheduled primary reverse total shoulder arthroplasty performed by J. Michael Wiater, MD.
- Patients age 18 and older
Exclusion Criteria:
- Pregnant* or breast-feeding women
- Allergy to tranexamic acid
- Acquired disturbances of color vision
- Use of estrogen containing medications (i.e. oral contraceptive pills)
- Hormone replacement therapy
- Preoperative anemia [Hemoglobin (Hb) < 11g/dL in females, Hb < 12 g/dL in males]
- Refusal of blood products
Preoperative use of anticoagulant therapy within 5 days prior to surgery
- Coumadin
- Heparin
- Low molecular weight heparin
- Factor Xa inhibitors
- Thrombin inhibitors
- Coagulopathy
- Thrombophilia
- Antithrombin deficiency
- Factor V Leiden
- Antiphospholipid Syndrome
- Protein C and S deficiency
- History of heparin induced thrombocytopenia
- Sickle cell anemia
- Myeloproliferative disorders
- Platelet < 150,00 mm3
- International Normalized Ratio (INR) > 1.4
- Partial Thromboplastin Time (PTT) > 1.4 times normal
- A history of arterial or venous thromboembolism
- Cerebral Vascular Accident
- Deep Vein Thrombosis
- Pulmonary Embolism
- Subarachnoid hemorrhage
- Active intravascular clotting
- Major comorbidities
- Coronary artery disease (New York Heart Association Class III or IV)
- Previous MI
- Severe pulmonary disease (FEV <50% normal)
- 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.
Sites / Locations
- William Beaumont Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Tranexamic acid
Normal Saline
Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.