TXA in Anticoagulated Patients Study

Study Overview
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Brief Summary
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This is a randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in anticoagulated patients who receive 2 doses of Tranexamic Acid (TXA) versus control group undergoing anatomical and reverse 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.

Official Title
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The Effect of Tranexamic Acid in Anticoagulated Patients Undergoing Total Shoulder Athroplasty

Conditions
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Total Shoulder Athroplasty

Intervention / Treatment
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* Drug: Tranexamic Acid Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients older than 18 years old Patients undergoing scheduled primary anatomic total shoulder arthroplasty Patients undergoing scheduled primary reverse total shoulder arthroplasty Patients who consent to be randomized Preoperative use of anticoagulant or antiplatelet therapy within 10 days prior to surgery: Coumadin (Warfarin) Heparin Low molecular weight heparin Factor Xa inhibitors Apixaban (Eliquis) Rivarixaban (Xatelto) Edoxaban (Savaysa) Dabigatran (Pradaxa) Clopidogrel (Plavix) Prasugrel (Effient) Ticagrelor (Brilinta) Exclusion Criteria Patients younger than 18 Patients who are pregnant* or breast-feeding women Patients who are allergic to tranexamic acid Patients scheduled for revision total shoulder arthroplasty 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

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
Interventional Model Description: Subjects scheduled to undergo TSA (anatomic and reverse) will be randomized to receive one of two treatment options. This study will utilize a simple randomization approach to generate two-equal groups. All subjects have an equal chance (1:2) of getting randomized into one of the twp treatments groups: (1) Two doses of IV TXA, one before incision and the second 3 hours later. (2) control group - no TXA given. Randomization of each subject will be done on day of surgery. The randomization schedule will be generated using a computer software program such as randomization.com
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>TXA | Drug: Tranexamic Acid Injection<br>* Injection of 1 gram of IV TXA before surgical plus 1 gram of IV TXA three hours later<br>|
| No Intervention: Group 2<br>no TXA | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pre-operative to POD 1 hemoglobin levels | On Post Operative Day 1, the floor nurse will draw and send a post op hemoglobin/hematocrit panel for all study patients prior to discharge. | Baseline to 24 hours post op | 
| Surgical drain output | Surgical drain output will be recorded by floor nurse every 8 hours in EPIC | 0-24 hours post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Formation of Hematoma | (yes or no) | 2 weeks | 
| Need for Post op blood transfusion | (yes or no) | 0-24 hours post op | 
| Operative time |  |  1-4 hours | 
| Development of adverse events |  | until 30 days after last day of study participation |