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

Rush University Medical Center110 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

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

Interventions

Tranexamic AcidDRUG

PlaceboDRUG

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Rush University Medical Center

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: Average of 3 days post-operatively

Secondary Outcomes

Number of Units Transfused

Units of pack red blood cells that the patients recieved

Time frame: Average of 3 days post-operatively

Number of Patients Transfused

Patients who received a post-op transfusion of pack red blood cells

Time frame: Average of 3 days post-operatively

Number of Participants With Deep Vein Thrombosis

Must be diagnosed via ultrasound duplex

Time frame: 30 days post-operative

Number of Participants With Pulmonary Embolism

Must be diagnosed via CT chest or V/Q lung scan

Time frame: 30 days post-operative

Number of Participants With Stroke

Must be diagnosed via CT scan or MRI

Time frame: 30 days post-operative

Data from ClinicalTrials.gov

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