TXA in Revision Total Shoulder Arthroplasty

Phase 4

Terminated

Brief Summary: This is a phase IV, randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in patients who receive 2 doses of Tranexamic Acid (TXA) versus control group undergoing revision total shoulder arthroplasty. Patients will be randomized to either receive 2 doses of IV TXA, first dose prior to surgical incision and second dose given 3 hours later or to the control group, where no TXA will be administered.

Detailed Description: The objectives of the study are to compare the effectiveness of IV TXA on reducing calculated total blood loss, surgical drain output and hematoma formation in patients undergoing revision total shoulder arthroplasty.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Patients younger than 18
Patients older than 90 years old
Patients who are pregnant or breast-feeding women
Patients who are allergic to tranexamic acid
Patients with proximal humerus fracture or fracture sequelae
Patients who use estrogen containing medications (i.e. oral contraceptive pills)
Patients who have acquired disturbances of color vision
Patients with a history of any of the following diagnosis: '
- Subarachnoid hemorrhage
- Active intravascular clotting
- Severe pulmonary disease (FEV <50% normal)
- Plasma creatinine > 115 μmol/L in males, > 100 μmol/L in females, or hepatic failure)
- (Renal impairment serum creatinine > 1.5 times the upper limit of normal NYU)
- Preoperative anemia [Hemoglobin (Hb) < 11g/dL in females, Hb < 12 g/dL in males]
Patients who refuse blood products
Patients undergoing hormone replacement therapy
Patients with diagnosed or self-reported cognitive dysfunction;
Patients who are unable to understand or follow instructions;
Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
Patients with BMI over 50
Any patient that the investigators feel cannot comply with all study related procedures.

Arm && Interventions

Group	Intervention	Description
Tranexamic acid (TXA) Injection	Tranexamic acid (TXA) injection	Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) will receive two injections of TXA.

Primary Outcome Measures

Name	Time	Method
Total Calculated Total Blood Loss	up to 24 hours post-op	The volume of perioperative blood loss will be determined on the basis of the blood volume and change in hemoglobin from preoperatively to 1 day postoperatively. The volume of total perioperative blood loss will be determined according to the following formula: Total blood loss (ml) = 1000 x 〖Hb〗_loss/〖Hb〗_i
Total Surgical Drain Output	up to 24 hours post-op	The floor nurse will also document the amount of blood in the indwelling hemovac surgical drain placed in the operative shoulder joint up to 24 hours. The total surgical drain output will be calculated after 24 hours.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Presence of Hematoma	2 weeks post-op	Surgeon will assess for presence of hematoma at the 2-week follow up visit.
Number of Participants Who Needed a Post-op Blood Transfusion	2 weeks post-op
Average Operative Time	During operation, up to 4 hours