TXA in Revision Total Shoulder Arthroplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Tranexamic Acid on Calculated Total Blood Loss in Patients Undergoing Revision Shoulder Arthroplasty

Conditions
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Arthropathy Shoulder

Intervention / Treatment
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* Drug: Tranexamic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years old Patients younger than 90 years old Patients undergoing scheduled revision total shoulder arthroplasty Patients who consent to be randomized 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid (TXA)<br>IV TXA | Drug: Tranexamic acid<br>* IV, Total Dosage: 2 grams (1 gram before surgical incision + 1 gram, 3 hours after first dose)<br>* Other names: TXA;|
| No Intervention: Control<br>No TXA | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total calculated total blood loss | 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 | up to 24 hours post-op | 
| Total surgical drain output | The floor nurse will also document the amount of blood in the indwelling hemovac surgical drain placed in the operative shoulder joint. The drain output will be documented every 8 hours. We will record the drain output for the first 16 hours after surgery - essentially 2 output shifts. If patients are in the hospital longer, we will record the third 24 hour drain output. | up to 24 hours post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with presence of hematoma |  | 2 weeks post-op | 
| Number of participants who needed a post-op blood transfusion |  | 2 weeks post-op | 
| Operative time |  | During operation, up to 4 hours |