Investigation of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty

Study Overview
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Brief Summary
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To compare intravenous Tranexamic Acid (TXA) versus normal saline placebo to determine whether or not TXA administration reduces blood loss, decrease in hemoglobin, and rate of transfusions following anatomic and reverse total shoulder arthroplasty (TSA) surgeries.

Detailed Description
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Anatomic and reverse total shoulder arthroplasty (TSA) is associated with the risk of moderate to significant blood loss that can lead to transfusions. Average estimated blood loss has been reported in the range of 354 to 361 mL intraoperatively, not accounting for additional postoperative blood loss postoperatively in surgical drains. Transfusion rates have been reported to range from 2.4% to 9.5% in recent studies, with rates over 30% for revision cases. Tranexamic acid (TXA) is a synthetic antifibrinolytic agent that is an established method of reducing blood loss and transfusion requirement for patients undergoing total hip and knee arthroplasty. TXA can be administered intravenously, topically (intraarticularly), or orally, with most available literature addressing intravenous and topical administration. Systematic reviews and meta-analyses of the total hip and knee arthroplasty literature demonstrate approximately a 30% decrease in blood loss and 50% decrease in transfusion rate with topical or intravenous administration of TXA compared to placebo. Moreover, the literature demonstrates no increased rate of thromboembolic or other complications associated with TXA administration for hip and knee arthroplasty. Despite proven efficacy in the hip and knee arthroplasty literature, there have been no studies analyzing the ability of TXA to reduce blood loss and transfusion rate following TSA. Purpose of the study is to compare intravenous Tranexamic Acid (TXA) versus normal saline placebo to determine whether or not TXA administration reduces blood loss, decrease in hemoglobin, and rate of transfusions following anatomic and reverse total shoulder arthroplasty (TSA) surgeries. With the hypothesis that intravenous TXA will reduce blood loss following TSA.

Official Title
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Investigation of the Blood Sparing Properties of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty

Conditions
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Blood Loss, Anatomic Total Shoulder Arthroplasty, Reverse Total Shoulder Arthroplasty, Transfusion, Tranexamic Acid

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient scheduled for a primary anatomic or reverse TSA Exclusion Criteria: Allergy to TXA Acquired disturbances of color vision Pre-op use of anticoagulant therapy within five days before surgery History of arterial or venous thromboembolic disease; such as DVT, PE, CVA, TIA Pregnancy or breastfeeding Recent MI (within 6 months of surgery) or any placement of stent regardless of time since placement Renal impairment Refusal of blood products Any patient undergoing a revision TSA Patients who decline to participate
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic Acid Group<br>Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision. | Drug: Tranexamic Acid<br> <br> |
| Placebo Comparator: Placebo Group<br>Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Blood Loss | Equated based on the patient's predicted blood volume and change in hemoglobin from the pre-operative level to the lowest post-operative level. | Average of 3 days post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Units Transfused | Units of pack red blood cells that the patients recieved | Average of 3 days post-operatively | 
| Number of Patients Transfused | Patients who received a post-op transfusion of pack red blood cells | Average of 3 days post-operatively | 
| Number of Participants With Deep Vein Thrombosis | Must be diagnosed via ultrasound duplex | 30 days post-operative | 
| Number of Participants With Pulmonary Embolism | Must be diagnosed via CT chest or V/Q lung scan | 30 days post-operative | 
| Number of Participants With Stroke | Must be diagnosed via CT scan or MRI | 30 days post-operative |