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

Rush

Status: Completed

Conditions: Reverse Total Shoulder Arthroplasty; Tranexamic Acid; Anatomic Total Shoulder Arthroplasty; Blood Loss; Transfusion

Treatments: Drug: Placebo; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02569658

Rush TXA TSA

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 110 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups, including a placebo group

Tranexamic Acid Group

Experimental group

Description:

Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.

Treatment:

Drug: Tranexamic Acid

Placebo Group

Placebo Comparator group

Description:

Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision

Treatment:

Drug: Placebo